Data stripping method to interrogate patient records and create anonymized record

ABSTRACT

Various surgical hubs and data stripping methods are disclosed. The surgical hub comprises a processor and a memory coupled to the processor. The memory stores instructions executable by the processor to interrogate a modular device coupled to the processor via a modular communication hub. The modular device is a source of data sets that include patient identity data and surgical procedure data. The processor also executes instructions to: receive a data set from the modular device; discard the patient identity data and any portion of the surgical procedure data that identifies the patient from the data set; extract anonymous data from the data set and create an anonymized data set; and configure operation of the surgical hub or the modular device based on the anonymized data set.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. patent application Ser. No.15/940,632, titled DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDSAND CREATE ANONYMIZED RECORD, filed Mar. 29, 2018, now U.S. PatentApplication Publication No. 2019/0205566, the disclosure of which isherein incorporated by reference in its entirety.

U.S. patent application Ser. No. 15/940,632 claims the benefit ofpriority under 35 U.S.C. 119(e) to U.S. Provisional Patent ApplicationSer. No. 62/649,294, titled DATA STRIPPING METHOD TO INTERROGATE PATIENTRECORDS AND CREATE ANONYMIZED RECORD, filed Mar. 28, 2018, thedisclosure of which is herein incorporated by reference in its entirety.

U.S. patent application Ser. No. 15/940,632 also claims the benefit ofpriority under 35 U.S.C. 119(e) to U.S. Provisional Patent ApplicationSer. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec.28, 2017, of U.S. Provisional Patent Application Ser. No. 62/611,340,titled CLOUD-BASED MEDICAL ANALYTICS, filed Dec. 28, 2017, of U.S.Provisional Patent Application Ser. No. 62/611,339, titled ROBOTASSISTED SURGICAL PLATFORM, filed Dec. 28, 2017, the disclosure of eachof which is herein incorporated by reference in its entirety.

BACKGROUND

The present disclosure relates to various surgical systems. Surgicalprocedures are typically performed in surgical operating theaters orrooms in a healthcare facility such as, for example, a hospital. Asterile field is typically created around the patient. The sterile fieldmay include the scrubbed team members, who are properly attired, and allfurniture and fixtures in the area. Various surgical devices and systemsare utilized in performance of a surgical procedure.

SUMMARY

In one general aspect, a surgical hub is provided. The surgical hubcomprises a processor and a memory coupled to the processor. The memorystores instructions executable by the processor to interrogate a modulardevice coupled to the processor via a modular communication hub. Themodular device is a source of data sets that include patient identitydata and surgical procedure data. The processor also executesinstructions to: receive a data set from the modular device; discard thepatient identity data and any portion of the surgical procedure datathat identifies the patient from the data set; extract anonymous datafrom the data set and create an anonymized data set; and configureoperation of the surgical hub or the modular device based on theanonymized data set.

In another general aspect, another surgical hub and data strippingmethod is provided. A surgical hub is coupled to a modular device by acommunication hub, and a method is provided of stripping dataoriginating from the modular device. The surgical hub comprises aprocessor and a memory coupled to the processor. The memory storesinstructions executable by the processor, comprising: interrogating, bya processor, a modular device coupled to the processor via a modularcommunication hub. The modular device is a source of data sets thatinclude patient identity data and surgical procedure data. The modularcommunication hub is configured to connect modular devices located inone or more operating theaters to a surgical hub. The memory storedinstructions executable by the processor further comprise: receiving, bythe processor, a data set from the modular device by the processor viathe communication hub; discarding, by the processor, the patientidentity data and any portion of the surgical procedure data thatidentifies the patient from the data set; extracting, by the processor,anonymous data from the data set and create an anonymized data set; andconfiguring, by the processor, operation of the surgical hub or themodular device based on the anonymized data set.

In yet another general aspect, a non-transitory computer-readable mediumstores computer-readable instructions that, when executed, cause amachine to: interrogate a modular device coupled to the processor viathe modular communication hub, wherein the modular device is a source ofdata sets that include patient identity data and surgical proceduredata; receive a data set from the modular device; discard the patientidentity data and any portion of the surgical procedure data thatidentifies the patient from the data set; extract anonymous data fromthe data set and create an anonymized data set; and configure operationof the surgical hub or the modular device based on the anonymized dataset.

FIGURES

The features of various aspects are set forth with particularity in theappended claims. The various aspects, however, both as to organizationand methods of operation, together with further objects and advantagesthereof, may best be understood by reference to the followingdescription, taken in conjunction with the accompanying drawings asfollows.

FIG. 1 is a block diagram of a computer-implemented interactive surgicalsystem, in accordance with at least one aspect of the presentdisclosure.

FIG. 2 is a surgical system being used to perform a surgical procedurein an operating room, in accordance with at least one aspect of thepresent disclosure.

FIG. 3 is a surgical hub paired with a visualization system, a roboticsystem, and an intelligent instrument, in accordance with at least oneaspect of the present disclosure.

FIG. 4 is a partial perspective view of a surgical hub enclosure, and ofa combo generator module slidably receivable in a drawer of the surgicalhub enclosure, in accordance with at least one aspect of the presentdisclosure.

FIG. 5 is a perspective view of a combo generator module with bipolar,ultrasonic, and monopolar contacts and a smoke evacuation component, inaccordance with at least one aspect of the present disclosure.

FIG. 6 illustrates individual power bus attachments for a plurality oflateral docking ports of a lateral modular housing configured to receivea plurality of modules, in accordance with at least one aspect of thepresent disclosure.

FIG. 7 illustrates a vertical modular housing configured to receive aplurality of modules, in accordance with at least one aspect of thepresent disclosure.

FIG. 8 illustrates a surgical data network comprising a modularcommunication hub configured to connect modular devices located in oneor more operating theaters of a healthcare facility, or any room in ahealthcare facility specially equipped for surgical operations, to thecloud, in accordance with at least one aspect of the present disclosure.

FIG. 9 illustrates a computer-implemented interactive surgical system,in accordance with at least one aspect of the present disclosure.

FIG. 10 illustrates a surgical hub comprising a plurality of modulescoupled to the modular control tower, in accordance with at least oneaspect of the present disclosure.

FIG. 11 illustrates one aspect of a Universal Serial Bus (USB) networkhub device, in accordance with at least one aspect of the presentdisclosure.

FIG. 12 illustrates a logic diagram of a control system of a surgicalinstrument or tool, in accordance with at least one aspect of thepresent disclosure.

FIG. 13 illustrates a control circuit configured to control aspects ofthe surgical instrument or tool, in accordance with at least one aspectof the present disclosure.

FIG. 14 illustrates a combinational logic circuit configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of the present disclosure.

FIG. 15 illustrates a sequential logic circuit configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of the present disclosure.

FIG. 16 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions, inaccordance with at least one aspect of the present disclosure.

FIG. 17 is a schematic diagram of a robotic surgical instrumentconfigured to operate a surgical tool described herein, in accordancewith at least one aspect of the present disclosure.

FIG. 18 illustrates a block diagram of a surgical instrument programmedto control the distal translation of a displacement member, inaccordance with at least one aspect of the present disclosure.

FIG. 19 is a schematic diagram of a surgical instrument configured tocontrol various functions, in accordance with at least one aspect of thepresent disclosure.

FIG. 20 is a simplified block diagram of a generator configured toprovide inductorless tuning, among other benefits, in accordance with atleast one aspect of the present disclosure.

FIG. 21 illustrates an example of a generator, which is one form of thegenerator of FIG. 20, in accordance with at least one aspect of thepresent disclosure.

FIG. 22 is a diagram illustrating a technique for interacting with apatient Electronic Medical Record (EMR) database, in accordance with atleast one aspect of the present disclosure.

FIG. 23 illustrates a process of anonymizing a surgical procedure bysubstituting an artificial time measure for a real time clock for allinformation stored internally within the instrument, robot, surgicalhub, and/or hospital computer equipment, in accordance with at least oneaspect of the present disclosure.

FIG. 24 illustrates ultrasonic pinging of an operating room wall todetermine a distance between a surgical hub and the operating room wall,in accordance with at least one aspect of the present disclosure.

FIG. 25 illustrates a diagram depicting the process of importing patientdata stored in an Electronic Medical Record (EMR) database, strippingthe patient data, and identifying smart device implications, inaccordance with at least one aspect of the present disclosure.

FIG. 26 illustrates the application of cloud based analytics to redactedand stripped patient data and independent data pairs, in accordance withat least one aspect of the present disclosure.

FIG. 27 is a logic flow diagram of a process depicting a control programor a logic configuration for associating patient data sets from firstand second sources of data, in accordance with at least one aspect ofthe present disclosure.

FIG. 28 is a logic flow diagram of a process depicting a control programor a logic configuration for stripping data to extract relevant portionsof the data to configure and operate the surgical hub and modules (e.g.,instruments) coupled to the surgical hub, in accordance with at leastone aspect of the present disclosure.

FIG. 29 illustrates a self-describing data packet comprisingself-describing data, in accordance with at least one aspect of thepresent disclosure.

FIG. 30 is a logic flow diagram of a process depicting a control programor a logic configuration for using data packets comprisingself-describing data, in accordance with at least one aspect of thepresent disclosure.

FIG. 31 is a logic flow diagram of a process depicting a control programor a logic configuration for using data packets comprisingself-describing data, in accordance with at least one aspect of thepresent disclosure.

FIG. 32 is a diagram of a tumor embedded in the right superior posteriorlobe of the right lung, in accordance with at least one aspect of thepresent disclosure.

FIG. 33 is a diagram of a lung tumor resection surgical procedureincluding four separate firings of a surgical stapler to seal and cutbronchial vessels exposed in the fissure leading to and from the upperand lower lobes of the right lung shown in FIG. 32, in accordance withat least one aspect of the present disclosure.

FIG. 34 is a graphical illustration of a force-to-close (FTC) versustime curve and a force-to-fire (FTF) versus time curve characterizingthe first firing of device 002 as shown in FIG. 32, in accordance withat least one aspect of the present disclosure.

FIG. 35 is a diagram of a staple line visualization laser Doppler toevaluate the integrity of staple line seals by monitoring bleeding of avessel after a firing of a surgical stapler, in accordance with at leastone aspect of the present disclosure.

FIG. 36 illustrates a paired data set grouped by surgery, in accordancewith at least one aspect of the present disclosure.

FIG. 37 is a diagram of the right lung.

FIG. 38 is a diagram of the bronchial tree including the trachea andbronchi of the lung.

FIG. 39 is a logic flow diagram of a process depicting a control programor a logic configuration for storing paired anonymous data sets groupedby surgery, in accordance with at least one aspect of the presentdisclosure.

FIG. 40 is a logic flow diagram of a process depicting a control programor a logic configuration for determining rate, frequency, and type ofdata to transfer to a remote cloud-based analytics network, inaccordance with at least one aspect of the present disclosure.

FIG. 41 is a timeline depicting situational awareness of a surgical hub,in accordance with at least one aspect of the present disclosure.

DESCRIPTION

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Mar. 28, 2018, each of which is hereinincorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/649,302, titled        INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION        CAPABILITIES;    -   U.S. Provisional Patent Application Ser. No. 62/649,294, titled        DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE        ANONYMIZED RECORD;    -   U.S. Provisional Patent Application Ser. No. 62/649,300, titled        SURGICAL HUB SITUATIONAL AWARENESS;    -   U.S. Provisional Patent Application Ser. No. 62/649,309, titled        SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING        THEATER;    -   U.S. Provisional Patent Application Ser. No. 62/649,310, titled        COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;    -   U.S. Provisional Patent Application Ser. No. 62/649,291, titled        USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE        PROPERTIES OF BACK SCATTERED LIGHT;    -   U.S. Provisional Patent Application Ser. No. 62/649,296, titled        ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/649,333, titled        CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND        RECOMMENDATIONS TO A USER;    -   U.S. Provisional Patent Application Ser. No. 62/649,327, titled        CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION        TRENDS AND REACTIVE MEASURES;    -   U.S. Provisional Patent Application Ser. No. 62/649,315, titled        DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK;    -   U.S. Provisional Patent Application Ser. No. 62/649,313, titled        CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/649,320, titled        DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. Provisional Patent Application Ser. No. 62/649,307, titled        AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL        PLATFORMS; and    -   U.S. Provisional Patent Application Ser. No. 62/649,323, titled        SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

Applicant of the present application owns the following U.S. patentapplications, filed on Mar. 29, 2018, each of which is hereinincorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 15/940,641, titled INTERACTIVE        SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES, now        U.S. Pat. No. 10,944,728;    -   U.S. patent application Ser. No. 15/940,648, titled INTERACTIVE        SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA        CAPABILITIES, now U.S. Patent Application Publication No.        2019/0206004;    -   U.S. patent application Ser. No. 15/940,656, titled SURGICAL HUB        COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM        DEVICES, now U.S. Patent Application Publication No.        2019/0201141;    -   U.S. patent application Ser. No. 15/940,666, titled SPATIAL        AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS, now U.S. Patent        Application Publication No. 2019/0206551;    -   U.S. patent application Ser. No. 15/940,670, titled COOPERATIVE        UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY        INTELLIGENT SURGICAL HUBS, now U.S. Patent Application        Publication No. 2019/0201116;    -   U.S. patent application Ser. No. 15/940,677, titled SURGICAL HUB        CONTROL ARRANGEMENTS, now U.S. Patent Application Publication        No. 2019/0201143;    -   U.S. patent application Ser. No. 15/940,640, titled        COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND        STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED        ANALYTICS SYSTEMS, now U.S. Patent Application Publication No.        2019/0200863;    -   U.S. patent application Ser. No. 15/940,645, titled SELF        DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT, now        U.S. Pat. No. 10,892,899;    -   U.S. patent application Ser. No. 15/940,649, titled DATA PAIRING        TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME, now        U.S. Patent Application Publication No. 2019/0205567;    -   U.S. patent application Ser. No. 15/940,654, titled SURGICAL HUB        SITUATIONAL AWARENESS, now U.S. Patent Application Publication        No. 2019/0201140;    -   U.S. patent application Ser. No. 15/940,663, titled SURGICAL        SYSTEM DISTRIBUTED PROCESSING, now U.S. Patent Application        Publication No. 2019/0201033;    -   U.S. patent application Ser. No. 15/940,668, titled AGGREGATION        AND REPORTING OF SURGICAL HUB DATA, now U.S. Patent Application        Publication No. 2019/0201115;    -   U.S. patent application Ser. No. 15/940,671, titled SURGICAL HUB        SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER, now        U.S. Patent Application Publication No. 2019/0201104;    -   U.S. patent application Ser. No. 15/940,686, titled DISPLAY OF        ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE, now        U.S. Patent Application Publication No. 2019/0201105;    -   U.S. patent application Ser. No. 15/940,700, titled STERILE        FIELD INTERACTIVE CONTROL DISPLAYS, now U.S. Patent Application        Publication No. 2019/0205001;    -   U.S. patent application Ser. No. 15/940,629, titled COMPUTER        IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS, now U.S. Patent        Application Publication No. 2019/0201112;    -   U.S. patent application Ser. No. 15/940,704, titled USE OF LASER        LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF        BACK SCATTERED LIGHT, now U.S. Patent Application Publication        No. 2019/0206050;    -   U.S. patent application Ser. No. 15/940,722, titled        CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF        MONO-CHROMATIC LIGHT REFRACTIVITY, now U.S. Patent Application        Publication No. 2019/0200905; and    -   U.S. patent application Ser. No. 15/940,742, titled DUAL CMOS        ARRAY IMAGING, now U.S. Patent Application Publication No.        2019/0200906.

Applicant of the present application owns the following U.S. patentapplications, filed on Mar. 29, 2018, each of which is hereinincorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 15/940,636, titled ADAPTIVE        CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES, now U.S. Patent        Application Publication No. 2019/0206003;    -   U.S. patent application Ser. No. 15/940,653, titled ADAPTIVE        CONTROL PROGRAM UPDATES FOR SURGICAL HUBS, now U.S. Patent        Application Publication No. 2019/0201114;    -   U.S. patent application Ser. No. 15/940,660, titled CLOUD-BASED        MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A        USER, now U.S. Patent Application Publication No. 2019/0206555;    -   U.S. patent application Ser. No. 15/940,679, titled CLOUD-BASED        MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE        RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET, now U.S. Pat.        No. 10,932,872;    -   U.S. patent application Ser. No. 15/940,694, titled CLOUD-BASED        MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED        INDIVIDUALIZATION OF INSTRUMENT FUNCTION, now U.S. Patent        Application Publication No. 2019/0201119;    -   U.S. patent application Ser. No. 15/940,634, titled CLOUD-BASED        MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND        REACTIVE MEASURES, now U.S. Patent Application Publication No.        2019/0201138;    -   U.S. patent application Ser. No. 15/940,706, titled DATA        HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK, now        U.S. Patent Application Publication No. 2019/0206561; and    -   U.S. patent application Ser. No. 15/940,675, titled CLOUD        INTERFACE FOR COUPLED SURGICAL DEVICES, now U.S. Pat. No.        10,849,697. Applicant of the present application owns the        following U.S. patent applications, filed on Mar. 29, 2018, each        of which is herein incorporated by reference in its entirety:    -   U.S. patent application Ser. No. 15/940,627, titled DRIVE        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS, now U.S.        Patent Application Publication No. 2019/0201111;    -   U.S. patent application Ser. No. 15/940,637, titled        COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL        PLATFORMS, now U.S. Patent Application Publication No.        2019/0201139;    -   U.S. patent application Ser. No. 15/940,642, titled CONTROLS FOR        ROBOT-ASSISTED SURGICAL PLATFORMS, now U.S. Patent Application        Publication No. 2019/0201113;    -   U.S. patent application Ser. No. 15/940,676, titled AUTOMATIC        TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS, now U.S.        Patent Application Publication No. 2019/0201142;    -   U.S. patent application Ser. No. 15/940,680, titled CONTROLLERS        FOR ROBOT-ASSISTED SURGICAL PLATFORMS, now U.S. Patent        Application Publication No. 2019/0201135;    -   U.S. patent application Ser. No. 15/940,683, titled COOPERATIVE        SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS, now U.S.        Patent Application Publication No. 2019/0201145;    -   U.S. patent application Ser. No. 15/940,690, titled DISPLAY        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS, now U.S.        Patent Application Publication No. 2019/0201118; and    -   U.S. patent application Ser. No. 15/940,711, titled SENSING        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS, now U.S.        Patent Application Publication No. 2019/0201120.

Before explaining various aspects of surgical devices and generators indetail, it should be noted that the illustrative examples are notlimited in application or use to the details of construction andarrangement of parts illustrated in the accompanying drawings anddescription. The illustrative examples may be implemented orincorporated in other aspects, variations and modifications, and may bepracticed or carried out in various ways. Further, unless otherwiseindicated, the terms and expressions employed herein have been chosenfor the purpose of describing the illustrative examples for theconvenience of the reader and are not for the purpose of limitationthereof. Also, it will be appreciated that one or more of thefollowing-described aspects, expressions of aspects, and/or examples,can be combined with any one or more of the other following-describedaspects, expressions of aspects and/or examples.

Referring to FIG. 1, a computer-implemented interactive surgical system100 includes one or more surgical systems 102 and a cloud-based system(e.g., the cloud 104 that may include a remote server 113 coupled to astorage device 105). Each surgical system 102 includes at least onesurgical hub 106 in communication with the cloud 104 that may include aremote server 113. In one example, as illustrated in FIG. 1, thesurgical system 102 includes a visualization system 108, a roboticsystem 110, and a handheld intelligent surgical instrument 112, whichare configured to communicate with one another and/or the hub 106. Insome aspects, a surgical system 102 may include an M number of hubs 106,an N number of visualization systems 108, an O number of robotic systems110, and a P number of handheld intelligent surgical instruments 112,where M, N, 0, and P are integers greater than or equal to one.

FIG. 3 depicts an example of a surgical system 102 being used to performa surgical procedure on a patient who is lying down on an operatingtable 114 in a surgical operating room 116. A robotic system 110 is usedin the surgical procedure as a part of the surgical system 102. Therobotic system 110 includes a surgeon's console 118, a patient side cart120 (surgical robot), and a surgical robotic hub 122. The patient sidecart 120 can manipulate at least one removably coupled surgical tool 117through a minimally invasive incision in the body of the patient whilethe surgeon views the surgical site through the surgeon's console 118.An image of the surgical site can be obtained by a medical imagingdevice 124, which can be manipulated by the patient side cart 120 toorient the imaging device 124. The robotic hub 122 can be used toprocess the images of the surgical site for subsequent display to thesurgeon through the surgeon's console 118.

Other types of robotic systems can be readily adapted for use with thesurgical system 102. Various examples of robotic systems and surgicaltools that are suitable for use with the present disclosure aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,339,titled ROBOT ASSISTED SURGICAL PLATFORM, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

Various examples of cloud-based analytics that are performed by thecloud 104, and are suitable for use with the present disclosure, aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,340,titled CLOUD-BASED MEDICAL ANALYTICS, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

In various aspects, the imaging device 124 includes at least one imagesensor and one or more optical components. Suitable image sensorsinclude, but are not limited to, Charge-Coupled Device (CCD) sensors andComplementary Metal-Oxide Semiconductor (CMOS) sensors.

The optical components of the imaging device 124 may include one or moreillumination sources and/or one or more lenses. The one or moreillumination sources may be directed to illuminate portions of thesurgical field. The one or more image sensors may receive lightreflected or refracted from the surgical field, including lightreflected or refracted from tissue and/or surgical instruments.

The one or more illumination sources may be configured to radiateelectromagnetic energy in the visible spectrum as well as the invisiblespectrum. The visible spectrum, sometimes referred to as the opticalspectrum or luminous spectrum, is that portion of the electromagneticspectrum that is visible to (i.e., can be detected by) the human eye andmay be referred to as visible light or simply light. A typical human eyewill respond to wavelengths in air that are from about 380 nm to about750 nm.

The invisible spectrum (i.e., the non-luminous spectrum) is that portionof the electromagnetic spectrum that lies below and above the visiblespectrum (i.e., wavelengths below about 380 nm and above about 750 nm).The invisible spectrum is not detectable by the human eye. Wavelengthsgreater than about 750 nm are longer than the red visible spectrum, andthey become invisible infrared (IR), microwave, and radioelectromagnetic radiation. Wavelengths less than about 380 nm areshorter than the violet spectrum, and they become invisible ultraviolet,x-ray, and gamma ray electromagnetic radiation.

In various aspects, the imaging device 124 is configured for use in aminimally invasive procedure. Examples of imaging devices suitable foruse with the present disclosure include, but not limited to, anarthroscope, angioscope, bronchoscope, choledochoscope, colonoscope,cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope(gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope,sigmoidoscope, thoracoscope, and ureteroscope.

In one aspect, the imaging device employs multi-spectrum monitoring todiscriminate topography and underlying structures. A multi-spectralimage is one that captures image data within specific wavelength rangesacross the electromagnetic spectrum. The wavelengths may be separated byfilters or by the use of instruments that are sensitive to particularwavelengths, including light from frequencies beyond the visible lightrange, e.g., IR and ultraviolet. Spectral imaging can allow extractionof additional information the human eye fails to capture with itsreceptors for red, green, and blue. The use of multi-spectral imaging isdescribed in greater detail under the heading “Advanced ImagingAcquisition Module” in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety. Multi-spectrum monitoring can be a useful tool in relocating asurgical field after a surgical task is completed to perform one or moreof the previously described tests on the treated tissue.

It is axiomatic that strict sterilization of the operating room andsurgical equipment is required during any surgery. The strict hygieneand sterilization conditions required in a “surgical theater,” i.e., anoperating or treatment room, necessitate the highest possible sterilityof all medical devices and equipment. Part of that sterilization processis the need to sterilize anything that comes in contact with the patientor penetrates the sterile field, including the imaging device 124 andits attachments and components. It will be appreciated that the sterilefield may be considered a specified area, such as within a tray or on asterile towel, that is considered free of microorganisms, or the sterilefield may be considered an area, immediately around a patient, who hasbeen prepared for a surgical procedure. The sterile field may includethe scrubbed team members, who are properly attired, and all furnitureand fixtures in the area.

In various aspects, the visualization system 108 includes one or moreimaging sensors, one or more image processing units, one or more storagearrays, and one or more displays that are strategically arranged withrespect to the sterile field, as illustrated in FIG. 2. In one aspect,the visualization system 108 includes an interface for HL7, PACS, andEMR. Various components of the visualization system 108 are describedunder the heading “Advanced Imaging Acquisition Module” in U.S.Provisional Patent Application Ser. No. 62/611,341, titled INTERACTIVESURGICAL PLATFORM, filed Dec. 28, 2017, the disclosure of which isherein incorporated by reference in its entirety.

As illustrated in FIG. 2, a primary display 119 is positioned in thesterile field to be visible to an operator at the operating table 114.In addition, a visualization tower 111 is positioned outside the sterilefield. The visualization tower 111 includes a first non-sterile display107 and a second non-sterile display 109, which face away from eachother. The visualization system 108, guided by the hub 106, isconfigured to utilize the displays 107, 109, and 119 to coordinateinformation flow to operators inside and outside the sterile field. Forexample, the hub 106 may cause the visualization system 108 to display asnap-shot of a surgical site, as recorded by an imaging device 124, on anon-sterile display 107 or 109, while maintaining a live feed of thesurgical site on the primary display 119. The snap-shot on thenon-sterile display 107 or 109 can permit a non-sterile operator toperform a diagnostic step relevant to the surgical procedure, forexample.

In one aspect, the hub 106 is also configured to route a diagnosticinput or feedback entered by a non-sterile operator at the visualizationtower 111 to the primary display 119 within the sterile field, where itcan be viewed by a sterile operator at the operating table. In oneexample, the input can be in the form of a modification to the snap-shotdisplayed on the non-sterile display 107 or 109, which can be routed tothe primary display 119 by the hub 106.

Referring to FIG. 2, a surgical instrument 112 is being used in thesurgical procedure as part of the surgical system 102. The hub 106 isalso configured to coordinate information flow to a display of thesurgical instrument 112. For example, in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, the disclosure of which is herein incorporated byreference in its entirety. A diagnostic input or feedback entered by anon-sterile operator at the visualization tower 111 can be routed by thehub 106 to the surgical instrument display 115 within the sterile field,where it can be viewed by the operator of the surgical instrument 112.Example surgical instruments that are suitable for use with the surgicalsystem 102 are described under the heading “Surgical InstrumentHardware” and in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety, for example.

Referring now to FIG. 3, a hub 106 is depicted in communication with avisualization system 108, a robotic system 110, and a handheldintelligent surgical instrument 112. The hub 106 includes a hub display135, an imaging module 138, a generator module 140, a communicationmodule 130, a processor module 132, and a storage array 134. In certainaspects, as illustrated in FIG. 3, the hub 106 further includes a smokeevacuation module 126 and/or a suction/irrigation module 128.

During a surgical procedure, energy application to tissue, for sealingand/or cutting, is generally associated with smoke evacuation, suctionof excess fluid, and/or irrigation of the tissue. Fluid, power, and/ordata lines from different sources are often entangled during thesurgical procedure. Valuable time can be lost addressing this issueduring a surgical procedure. Detangling the lines may necessitatedisconnecting the lines from their respective modules, which may requireresetting the modules. The hub modular enclosure 136 offers a unifiedenvironment for managing the power, data, and fluid lines, which reducesthe frequency of entanglement between such lines.

Aspects of the present disclosure present a surgical hub for use in asurgical procedure that involves energy application to tissue at asurgical site. The surgical hub includes a hub enclosure and a combogenerator module slidably receivable in a docking station of the hubenclosure. The docking station includes data and power contacts. Thecombo generator module includes two or more of an ultrasonic energygenerator component, a bipolar RF energy generator component, and amonopolar RF energy generator component that are housed in a singleunit. In one aspect, the combo generator module also includes a smokeevacuation component, at least one energy delivery cable for connectingthe combo generator module to a surgical instrument, at least one smokeevacuation component configured to evacuate smoke, fluid, and/orparticulates generated by the application of therapeutic energy to thetissue, and a fluid line extending from the remote surgical site to thesmoke evacuation component.

In one aspect, the fluid line is a first fluid line and a second fluidline extends from the remote surgical site to a suction and irrigationmodule slidably received in the hub enclosure. In one aspect, the hubenclosure comprises a fluid interface.

Certain surgical procedures may require the application of more than oneenergy type to the tissue. One energy type may be more beneficial forcutting the tissue, while another different energy type may be morebeneficial for sealing the tissue. For example, a bipolar generator canbe used to seal the tissue while an ultrasonic generator can be used tocut the sealed tissue. Aspects of the present disclosure present asolution where a hub modular enclosure 136 is configured to accommodatedifferent generators, and facilitate an interactive communicationtherebetween. One of the advantages of the hub modular enclosure 136 isenabling the quick removal and/or replacement of various modules.

Aspects of the present disclosure present a modular surgical enclosurefor use in a surgical procedure that involves energy application totissue. The modular surgical enclosure includes a first energy-generatormodule, configured to generate a first energy for application to thetissue, and a first docking station comprising a first docking port thatincludes first data and power contacts, wherein the firstenergy-generator module is slidably movable into an electricalengagement with the power and data contacts and wherein the firstenergy-generator module is slidably movable out of the electricalengagement with the first power and data contacts.

Further to the above, the modular surgical enclosure also includes asecond energy-generator module configured to generate a second energy,different than the first energy, for application to the tissue, and asecond docking station comprising a second docking port that includessecond data and power contacts, wherein the second energy-generatormodule is slidably movable into an electrical engagement with the powerand data contacts, and wherein the second energy-generator module isslidably movable out of the electrical engagement with the second powerand data contacts.

In addition, the modular surgical enclosure also includes acommunication bus between the first docking port and the second dockingport, configured to facilitate communication between the firstenergy-generator module and the second energy-generator module.

Referring to FIGS. 3-7, aspects of the present disclosure are presentedfor a hub modular enclosure 136 that allows the modular integration of agenerator module 140, a smoke evacuation module 126, and asuction/irrigation module 128. The hub modular enclosure 136 furtherfacilitates interactive communication between the modules 140, 126, 128.As illustrated in FIG. 5, the generator module 140 can be a generatormodule with integrated monopolar, bipolar, and ultrasonic componentssupported in a single housing unit 139 slidably insertable into the hubmodular enclosure 136. As illustrated in FIG. 5, the generator module140 can be configured to connect to a monopolar device 146, a bipolardevice 147, and an ultrasonic device 148. Alternatively, the generatormodule 140 may comprise a series of monopolar, bipolar, and/orultrasonic generator modules that interact through the hub modularenclosure 136. The hub modular enclosure 136 can be configured tofacilitate the insertion of multiple generators and interactivecommunication between the generators docked into the hub modularenclosure 136 so that the generators would act as a single generator.

In one aspect, the hub modular enclosure 136 comprises a modular powerand communication backplane 149 with external and wireless communicationheaders to enable the removable attachment of the modules 140, 126, 128and interactive communication therebetween.

In one aspect, the hub modular enclosure 136 includes docking stations,or drawers, 151, herein also referred to as drawers, which areconfigured to slidably receive the modules 140, 126, 128. FIG. 4illustrates a partial perspective view of a surgical hub enclosure 136,and a combo generator module 145 slidably receivable in a dockingstation 151 of the surgical hub enclosure 136. A docking port 152 withpower and data contacts on a rear side of the combo generator module 145is configured to engage a corresponding docking port 150 with power anddata contacts of a corresponding docking station 151 of the hub modularenclosure 136 as the combo generator module 145 is slid into positionwithin the corresponding docking station 151 of the hub module enclosure136. In one aspect, the combo generator module 145 includes a bipolar,ultrasonic, and monopolar module and a smoke evacuation moduleintegrated together into a single housing unit 139, as illustrated inFIG. 5.

In various aspects, the smoke evacuation module 126 includes a fluidline 154 that conveys captured/collected smoke and/or fluid away from asurgical site and to, for example, the smoke evacuation module 126.Vacuum suction originating from the smoke evacuation module 126 can drawthe smoke into an opening of a utility conduit at the surgical site. Theutility conduit, coupled to the fluid line, can be in the form of aflexible tube terminating at the smoke evacuation module 126. Theutility conduit and the fluid line define a fluid path extending towardthe smoke evacuation module 126 that is received in the hub enclosure136.

In various aspects, the suction/irrigation module 128 is coupled to asurgical tool comprising an aspiration fluid line and a suction fluidline. In one example, the aspiration and suction fluid lines are in theform of flexible tubes extending from the surgical site toward thesuction/irrigation module 128. One or more drive systems can beconfigured to cause irrigation and aspiration of fluids to and from thesurgical site.

In one aspect, the surgical tool includes a shaft having an end effectorat a distal end thereof and at least one energy treatment associatedwith the end effector, an aspiration tube, and an irrigation tube. Theaspiration tube can have an inlet port at a distal end thereof and theaspiration tube extends through the shaft. Similarly, an irrigation tubecan extend through the shaft and can have an inlet port in proximity tothe energy deliver implement. The energy deliver implement is configuredto deliver ultrasonic and/or RF energy to the surgical site and iscoupled to the generator module 140 by a cable extending initiallythrough the shaft.

The irrigation tube can be in fluid communication with a fluid source,and the aspiration tube can be in fluid communication with a vacuumsource. The fluid source and/or the vacuum source can be housed in thesuction/irrigation module 128. In one example, the fluid source and/orthe vacuum source can be housed in the hub enclosure 136 separately fromthe suction/irrigation module 128. In such example, a fluid interfacecan be configured to connect the suction/irrigation module 128 to thefluid source and/or the vacuum source.

In one aspect, the modules 140, 126, 128 and/or their correspondingdocking stations on the hub modular enclosure 136 may include alignmentfeatures that are configured to align the docking ports of the modulesinto engagement with their counterparts in the docking stations of thehub modular enclosure 136. For example, as illustrated in FIG. 4, thecombo generator module 145 includes side brackets 155 that areconfigured to slidably engage with corresponding brackets 156 of thecorresponding docking station 151 of the hub modular enclosure 136. Thebrackets cooperate to guide the docking port contacts of the combogenerator module 145 into an electrical engagement with the docking portcontacts of the hub modular enclosure 136.

In some aspects, the drawers 151 of the hub modular enclosure 136 arethe same, or substantially the same size, and the modules are adjustedin size to be received in the drawers 151. For example, the sidebrackets 155 and/or 156 can be larger or smaller depending on the sizeof the module. In other aspects, the drawers 151 are different in sizeand are each designed to accommodate a particular module.

Furthermore, the contacts of a particular module can be keyed forengagement with the contacts of a particular drawer to avoid inserting amodule into a drawer with mismatching contacts.

As illustrated in FIG. 4, the docking port 150 of one drawer 151 can becoupled to the docking port 150 of another drawer 151 through acommunications link 157 to facilitate an interactive communicationbetween the modules housed in the hub modular enclosure 136. The dockingports 150 of the hub modular enclosure 136 may alternatively, oradditionally, facilitate a wireless interactive communication betweenthe modules housed in the hub modular enclosure 136. Any suitablewireless communication can be employed, such as for example AirTitan-Bluetooth.

FIG. 6 illustrates individual power bus attachments for a plurality oflateral docking ports of a lateral modular housing 160 configured toreceive a plurality of modules of a surgical hub 206. The lateralmodular housing 160 is configured to laterally receive and interconnectthe modules 161. The modules 161 are slidably inserted into dockingstations 162 of lateral modular housing 160, which includes a backplanefor interconnecting the modules 161. As illustrated in FIG. 6, themodules 161 are arranged laterally in the lateral modular housing 160.Alternatively, the modules 161 may be arranged vertically in a lateralmodular housing.

FIG. 7 illustrates a vertical modular housing 164 configured to receivea plurality of modules 165 of the surgical hub 106. The modules 165 areslidably inserted into docking stations, or drawers, 167 of verticalmodular housing 164, which includes a backplane for interconnecting themodules 165. Although the drawers 167 of the vertical modular housing164 are arranged vertically, in certain instances, a vertical modularhousing 164 may include drawers that are arranged laterally.Furthermore, the modules 165 may interact with one another through thedocking ports of the vertical modular housing 164. In the example ofFIG. 7, a display 177 is provided for displaying data relevant to theoperation of the modules 165. In addition, the vertical modular housing164 includes a master module 178 housing a plurality of sub-modules thatare slidably received in the master module 178.

In various aspects, the imaging module 138 comprises an integrated videoprocessor and a modular light source and is adapted for use with variousimaging devices. In one aspect, the imaging device is comprised of amodular housing that can be assembled with a light source module and acamera module. The housing can be a disposable housing. In at least oneexample, the disposable housing is removably coupled to a reusablecontroller, a light source module, and a camera module. The light sourcemodule and/or the camera module can be selectively chosen depending onthe type of surgical procedure. In one aspect, the camera modulecomprises a CCD sensor. In another aspect, the camera module comprises aCMOS sensor. In another aspect, the camera module is configured forscanned beam imaging. Likewise, the light source module can beconfigured to deliver a white light or a different light, depending onthe surgical procedure.

During a surgical procedure, removing a surgical device from thesurgical field and replacing it with another surgical device thatincludes a different camera or a different light source can beinefficient. Temporarily losing sight of the surgical field may lead toundesirable consequences. The module imaging device of the presentdisclosure is configured to permit the replacement of a light sourcemodule or a camera module midstream during a surgical procedure, withouthaving to remove the imaging device from the surgical field.

In one aspect, the imaging device comprises a tubular housing thatincludes a plurality of channels. A first channel is configured toslidably receive the camera module, which can be configured for asnap-fit engagement with the first channel. A second channel isconfigured to slidably receive the light source module, which can beconfigured for a snap-fit engagement with the second channel. In anotherexample, the camera module and/or the light source module can be rotatedinto a final position within their respective channels. A threadedengagement can be employed in lieu of the snap-fit engagement.

In various examples, multiple imaging devices are placed at differentpositions in the surgical field to provide multiple views. The imagingmodule 138 can be configured to switch between the imaging devices toprovide an optimal view. In various aspects, the imaging module 138 canbe configured to integrate the images from the different imaging device.

Various image processors and imaging devices suitable for use with thepresent disclosure are described in U.S. Pat. No. 7,995,045, titledCOMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR, which issued on Aug. 9,2011, which is herein incorporated by reference in its entirety. Inaddition, U.S. Pat. No. 7,982,776, titled SBI MOTION ARTIFACT REMOVALAPPARATUS AND METHOD, which issued on Jul. 19, 2011, which is hereinincorporated by reference in its entirety, describes various systems forremoving motion artifacts from image data. Such systems can beintegrated with the imaging module 138. Furthermore, U.S. PatentApplication Publication No. 2011/0306840, titled CONTROLLABLE MAGNETICSOURCE TO FIXTURE INTRACORPOREAL APPARATUS, which published on Dec. 15,2011, and U.S. Pat. No. 10,098,527, titled SYSTEM FOR PERFORMING AMINIMALLY INVASIVE SURGICAL PROCEDURE, which issued on Oct. 16, 2018,each of which is herein incorporated by reference in its entirety.

FIG. 8 illustrates a surgical data network 201 comprising a modularcommunication hub 203 configured to connect modular devices located inone or more operating theaters of a healthcare facility, or any room ina healthcare facility specially equipped for surgical operations, to acloud-based system (e.g., the cloud 204 that may include a remote server213 coupled to a storage device 205). In one aspect, the modularcommunication hub 203 comprises a network hub 207 and/or a networkswitch 209 in communication with a network router. The modularcommunication hub 203 also can be coupled to a local computer system 210to provide local computer processing and data manipulation. The surgicaldata network 201 may be configured as passive, intelligent, orswitching. A passive surgical data network serves as a conduit for thedata, enabling it to go from one device (or segment) to another and tothe cloud computing resources. An intelligent surgical data networkincludes additional features to enable the traffic passing through thesurgical data network to be monitored and to configure each port in thenetwork hub 207 or network switch 209. An intelligent surgical datanetwork may be referred to as a manageable hub or switch. A switchinghub reads the destination address of each packet and then forwards thepacket to the correct port.

Modular devices 1 a-1 n located in the operating theater may be coupledto the modular communication hub 203. The network hub 207 and/or thenetwork switch 209 may be coupled to a network router 211 to connect thedevices 1 a-1 n to the cloud 204 or the local computer system 210. Dataassociated with the devices 1 a-1 n may be transferred to cloud-basedcomputers via the router for remote data processing and manipulation.Data associated with the devices 1 a-1 n may also be transferred to thelocal computer system 210 for local data processing and manipulation.Modular devices 2 a-2 m located in the same operating theater also maybe coupled to a network switch 209. The network switch 209 may becoupled to the network hub 207 and/or the network router 211 to connectto the devices 2 a-2 m to the cloud 204. Data associated with thedevices 2 a-2 n may be transferred to the cloud 204 via the networkrouter 211 for data processing and manipulation. Data associated withthe devices 2 a-2 m may also be transferred to the local computer system210 for local data processing and manipulation.

It will be appreciated that the surgical data network 201 may beexpanded by interconnecting multiple network hubs 207 and/or multiplenetwork switches 209 with multiple network routers 211. The modularcommunication hub 203 may be contained in a modular control towerconfigured to receive multiple devices 1 a-1 n/2 a-2 m. The localcomputer system 210 also may be contained in a modular control tower.The modular communication hub 203 is connected to a display 212 todisplay images obtained by some of the devices 1 a-1 n/2 a-2 m, forexample during surgical procedures. In various aspects, the devices 1a-1 n/2 a-2 m may include, for example, various modules such as animaging module 138 coupled to an endoscope, a generator module 140coupled to an energy-based surgical device, a smoke evacuation module126, a suction/irrigation module 128, a communication module 130, aprocessor module 132, a storage array 134, a surgical device coupled toa display, and/or a non-contact sensor module, among other modulardevices that may be connected to the modular communication hub 203 ofthe surgical data network 201.

In one aspect, the surgical data network 201 may comprise a combinationof network hub(s), network switch(es), and network router(s) connectingthe devices 1 a-1 n/2 a-2 m to the cloud. Any one of or all of thedevices 1 a-1 n/2 a-2 m coupled to the network hub or network switch maycollect data in real time and transfer the data to cloud computers fordata processing and manipulation. It will be appreciated that cloudcomputing relies on sharing computing resources rather than having localservers or personal devices to handle software applications. The word“cloud” may be used as a metaphor for “the Internet,” although the termis not limited as such. Accordingly, the term “cloud computing” may beused herein to refer to “a type of Internet-based computing,” wheredifferent services—such as servers, storage, and applications—aredelivered to the modular communication hub 203 and/or computer system210 located in the surgical theater (e.g., a fixed, mobile, temporary,or field operating room or space) and to devices connected to themodular communication hub 203 and/or computer system 210 through theInternet. The cloud infrastructure may be maintained by a cloud serviceprovider. In this context, the cloud service provider may be the entitythat coordinates the usage and control of the devices 1 a-1 n/2 a-2 mlocated in one or more operating theaters. The cloud computing servicescan perform a large number of calculations based on the data gathered bysmart surgical instruments, robots, and other computerized deviceslocated in the operating theater. The hub hardware enables multipledevices or connections to be connected to a computer that communicateswith the cloud computing resources and storage.

Applying cloud computer data processing techniques on the data collectedby the devices 1 a-1 n/2 a-2 m, the surgical data network providesimproved surgical outcomes, reduced costs, and improved patientsatisfaction. At least some of the devices 1 a-1 n/2 a-2 m may beemployed to view tissue states to assess leaks or perfusion of sealedtissue after a tissue sealing and cutting procedure. At least some ofthe devices 1 a-1 n/2 a-2 m may be employed to identify pathology, suchas the effects of diseases, using the cloud-based computing to examinedata including images of samples of body tissue for diagnostic purposes.This includes localization and margin confirmation of tissue andphenotypes. At least some of the devices 1 a-1 n/2 a-2 m may be employedto identify anatomical structures of the body using a variety of sensorsintegrated with imaging devices and techniques such as overlaying imagescaptured by multiple imaging devices. The data gathered by the devices 1a-1 n/2 a-2 m, including image data, may be transferred to the cloud 204or the local computer system 210 or both for data processing andmanipulation including image processing and manipulation. The data maybe analyzed to improve surgical procedure outcomes by determining iffurther treatment, such as the application of endoscopic intervention,emerging technologies, a targeted radiation, targeted intervention, andprecise robotics to tissue-specific sites and conditions, may bepursued. Such data analysis may further employ outcome analyticsprocessing, and using standardized approaches may provide beneficialfeedback to either confirm surgical treatments and the behavior of thesurgeon or suggest modifications to surgical treatments and the behaviorof the surgeon.

In one implementation, the operating theater devices 1 a-1 n may beconnected to the modular communication hub 203 over a wired channel or awireless channel depending on the configuration of the devices 1 a-1 nto a network hub. The network hub 207 may be implemented, in one aspect,as a local network broadcast device that works on the physical layer ofthe Open System Interconnection (OSI) model. The network hub providesconnectivity to the devices 1 a-1 n located in the same operatingtheater network. The network hub 207 collects data in the form ofpackets and sends them to the router in half duplex mode. The networkhub 207 does not store any media access control/internet protocol(MAC/IP) to transfer the device data. Only one of the devices 1 a-1 ncan send data at a time through the network hub 207. The network hub 207has no routing tables or intelligence regarding where to sendinformation and broadcasts all network data across each connection andto a remote server 213 (FIG. 9) over the cloud 204. The network hub 207can detect basic network errors such as collisions, but having allinformation broadcast to multiple ports can be a security risk and causebottlenecks.

In another implementation, the operating theater devices 2 a-2 m may beconnected to a network switch 209 over a wired channel or a wirelesschannel. The network switch 209 works in the data link layer of the OSImodel. The network switch 209 is a multicast device for connecting thedevices 2 a-2 m located in the same operating theater to the network.The network switch 209 sends data in the form of frames to the networkrouter 211 and works in full duplex mode. Multiple devices 2 a-2 m cansend data at the same time through the network switch 209. The networkswitch 209 stores and uses MAC addresses of the devices 2 a-2 m totransfer data.

The network hub 207 and/or the network switch 209 are coupled to thenetwork router 211 for connection to the cloud 204. The network router211 works in the network layer of the OSI model. The network router 211creates a route for transmitting data packets received from the networkhub 207 and/or network switch 211 to cloud-based computer resources forfurther processing and manipulation of the data collected by any one ofor all the devices 1 a-1 n/2 a-2 m. The network router 211 may beemployed to connect two or more different networks located in differentlocations, such as, for example, different operating theaters of thesame healthcare facility or different networks located in differentoperating theaters of different healthcare facilities. The networkrouter 211 sends data in the form of packets to the cloud 204 and worksin full duplex mode. Multiple devices can send data at the same time.The network router 211 uses IP addresses to transfer data.

In one example, the network hub 207 may be implemented as a USB hub,which allows multiple USB devices to be connected to a host computer.The USB hub may expand a single USB port into several tiers so thatthere are more ports available to connect devices to the host systemcomputer. The network hub 207 may include wired or wireless capabilitiesto receive information over a wired channel or a wireless channel. Inone aspect, a wireless USB short-range, high-bandwidth wireless radiocommunication protocol may be employed for communication between thedevices 1 a-1 n and devices 2 a-2 m located in the operating theater.

In other examples, the operating theater devices 1 a-1 n/2 a-2 m maycommunicate to the modular communication hub 203 via Bluetooth wirelesstechnology standard for exchanging data over short distances (usingshort-wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz)from fixed and mobile devices and building personal area networks(PANs). In other aspects, the operating theater devices 1 a-1 n/2 a-2 mmay communicate to the modular communication hub 203 via a number ofwireless or wired communication standards or protocols, including butnot limited to Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family),IEEE 802.20, long-term evolution (LTE), and Ev-DO, HSPA+, HSDPA+,HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivativesthereof, as well as any other wireless and wired protocols that aredesignated as 3G, 4G, 5G, and beyond. The computing module may include aplurality of communication modules. For instance, a first communicationmodule may be dedicated to shorter-range wireless communications such asWi-Fi and Bluetooth, and a second communication module may be dedicatedto longer-range wireless communications such as GPS, EDGE, GPRS, CDMA,WiMAX, LTE, Ev-DO, and others.

The modular communication hub 203 may serve as a central connection forone or all of the operating theater devices 1 a-1 n/2 a-2 m and handlesa data type known as frames. Frames carry the data generated by thedevices 1 a-1 n/2 a-2 m. When a frame is received by the modularcommunication hub 203, it is amplified and transmitted to the networkrouter 211, which transfers the data to the cloud computing resources byusing a number of wireless or wired communication standards orprotocols, as described herein.

The modular communication hub 203 can be used as a standalone device orbe connected to compatible network hubs and network switches to form alarger network. The modular communication hub 203 is generally easy toinstall, configure, and maintain, making it a good option for networkingthe operating theater devices 1 a-1 n/2 a-2 m.

FIG. 9 illustrates a computer-implemented interactive surgical system200. The computer-implemented interactive surgical system 200 is similarin many respects to the computer-implemented interactive surgical system100. For example, the computer-implemented interactive surgical system200 includes one or more surgical systems 202, which are similar in manyrespects to the surgical systems 102. Each surgical system 202 includesat least one surgical hub 206 in communication with a cloud 204 that mayinclude a remote server 213. In one aspect, the computer-implementedinteractive surgical system 200 comprises a modular control tower 236connected to multiple operating theater devices such as, for example,intelligent surgical instruments, robots, and other computerized deviceslocated in the operating theater. As shown in FIG. 10, the modularcontrol tower 236 comprises a modular communication hub 203 coupled to acomputer system 210. As illustrated in the example of FIG. 9, themodular control tower 236 is coupled to an imaging module 238 that iscoupled to an endoscope 239, a generator module 240 that is coupled toan energy device 241, a smoke evacuator module 226, a suction/irrigationmodule 228, a communication module 230, a processor module 232, astorage array 234, a smart device/instrument 235 optionally coupled to adisplay 237, and a non-contact sensor module 242. The operating theaterdevices are coupled to cloud computing resources and data storage viathe modular control tower 236. A robot hub 222 also may be connected tothe modular control tower 236 and to the cloud computing resources. Thedevices/instruments 235, visualization systems 208, among others, may becoupled to the modular control tower 236 via wired or wirelesscommunication standards or protocols, as described herein. The modularcontrol tower 236 may be coupled to a hub display 215 (e.g., monitor,screen) to display and overlay images received from the imaging module,device/instrument display, and/or other visualization systems 208. Thehub display also may display data received from devices connected to themodular control tower in conjunction with images and overlaid images.

FIG. 10 illustrates a surgical hub 206 comprising a plurality of modulescoupled to the modular control tower 236. The modular control tower 236comprises a modular communication hub 203, e.g., a network connectivitydevice, and a computer system 210 to provide local processing,visualization, and imaging, for example. As shown in FIG. 10, themodular communication hub 203 may be connected in a tiered configurationto expand the number of modules (e.g., devices) that may be connected tothe modular communication hub 203 and transfer data associated with themodules to the computer system 210, cloud computing resources, or both.As shown in FIG. 10, each of the network hubs/switches in the modularcommunication hub 203 includes three downstream ports and one upstreamport. The upstream network hub/switch is connected to a processor toprovide a communication connection to the cloud computing resources anda local display 217. Communication to the cloud 204 may be made eitherthrough a wired or a wireless communication channel.

The surgical hub 206 employs a non-contact sensor module 242 to measurethe dimensions of the operating theater and generate a map of thesurgical theater using either ultrasonic or laser-type non-contactmeasurement devices. An ultrasound-based non-contact sensor module scansthe operating theater by transmitting a burst of ultrasound andreceiving the echo when it bounces off the perimeter walls of anoperating theater as described under the heading “Surgical Hub SpatialAwareness Within an Operating Room” in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, which is herein incorporated by reference in itsentirety, in which the sensor module is configured to determine the sizeof the operating theater and to adjust Bluetooth-pairing distancelimits. A laser-based non-contact sensor module scans the operatingtheater by transmitting laser light pulses, receiving laser light pulsesthat bounce off the perimeter walls of the operating theater, andcomparing the phase of the transmitted pulse to the received pulse todetermine the size of the operating theater and to adjust Bluetoothpairing distance limits, for example.

The computer system 210 comprises a processor 244 and a networkinterface 245. The processor 244 is coupled to a communication module247, storage 248, memory 249, non-volatile memory 250, and input/outputinterface 251 via a system bus. The system bus can be any of severaltypes of bus structure(s) including the memory bus or memory controller,a peripheral bus or external bus, and/or a local bus using any varietyof available bus architectures including, but not limited to, 9-bit bus,Industrial Standard Architecture (ISA), Micro-Charmel Architecture(MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESALocal Bus (VLB), Peripheral Component Interconnect (PCI), USB, AdvancedGraphics Port (AGP), Personal Computer Memory Card InternationalAssociation bus (PCMCIA), Small Computer Systems Interface (SCSI), orany other proprietary bus.

The processor 244 may be any single-core or multicore processor such asthose known under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising anon-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), an internal read-only memory (ROM) loaded withStellarisWare® software, a 2 KB electrically erasable programmableread-only memory (EEPROM), and/or one or more pulse width modulation(PWM) modules, one or more quadrature encoder inputs (QEI) analogs, oneor more 12-bit analog-to-digital converters (ADCs) with 12 analog inputchannels, details of which are available for the product datasheet.

In one aspect, the processor 244 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The system memory includes volatile memory and non-volatile memory. Thebasic input/output system (BIOS), containing the basic routines totransfer information between elements within the computer system, suchas during start-up, is stored in non-volatile memory. For example, thenon-volatile memory can include ROM, programmable ROM (PROM),electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatilememory includes random-access memory (RAM), which acts as external cachememory. Moreover, RAM is available in many forms such as SRAM, dynamicRAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and directRambus RAM (DRRAM).

The computer system 210 also includes removable/non-removable,volatile/non-volatile computer storage media, such as for example diskstorage. The disk storage includes, but is not limited to, devices likea magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zipdrive, LS-60 drive, flash memory card, or memory stick. In addition, thedisk storage can include storage media separately or in combination withother storage media including, but not limited to, an optical disc drivesuch as a compact disc ROM device (CD-ROM), compact disc recordabledrive (CD-R Drive), compact disc rewritable drive (CD-RW Drive), or adigital versatile disc ROM drive (DVD-ROM). To facilitate the connectionof the disk storage devices to the system bus, a removable ornon-removable interface may be employed.

It is to be appreciated that the computer system 210 includes softwarethat acts as an intermediary between users and the basic computerresources described in a suitable operating environment. Such softwareincludes an operating system. The operating system, which can be storedon the disk storage, acts to control and allocate resources of thecomputer system. System applications take advantage of the management ofresources by the operating system through program modules and programdata stored either in the system memory or on the disk storage. It is tobe appreciated that various components described herein can beimplemented with various operating systems or combinations of operatingsystems.

A user enters commands or information into the computer system 210through input device(s) coupled to the I/O interface 251. The inputdevices include, but are not limited to, a pointing device such as amouse, trackball, stylus, touch pad, keyboard, microphone, joystick,game pad, satellite dish, scanner, TV tuner card, digital camera,digital video camera, web camera, and the like. These and other inputdevices connect to the processor through the system bus via interfaceport(s). The interface port(s) include, for example, a serial port, aparallel port, a game port, and a USB. The output device(s) use some ofthe same types of ports as input device(s). Thus, for example, a USBport may be used to provide input to the computer system and to outputinformation from the computer system to an output device. An outputadapter is provided to illustrate that there are some output deviceslike monitors, displays, speakers, and printers, among other outputdevices that require special adapters. The output adapters include, byway of illustration and not limitation, video and sound cards thatprovide a means of connection between the output device and the systembus. It should be noted that other devices and/or systems of devices,such as remote computer(s), provide both input and output capabilities.

The computer system 210 can operate in a networked environment usinglogical connections to one or more remote computers, such as cloudcomputer(s), or local computers. The remote cloud computer(s) can be apersonal computer, server, router, network PC, workstation,microprocessor-based appliance, peer device, or other common networknode, and the like, and typically includes many or all of the elementsdescribed relative to the computer system. For purposes of brevity, onlya memory storage device is illustrated with the remote computer(s). Theremote computer(s) is logically connected to the computer system througha network interface and then physically connected via a communicationconnection. The network interface encompasses communication networkssuch as local area networks (LANs) and wide area networks (WANs). LANtechnologies include Fiber Distributed Data Interface (FDDI), CopperDistributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE802.5 and the like. WAN technologies include, but are not limited to,point-to-point links, circuit-switching networks like IntegratedServices Digital Networks (ISDN) and variations thereon,packet-switching networks, and Digital Subscriber Lines (DSL).

In various aspects, the computer system 210 of FIG. 10, the imagingmodule 238 and/or visualization system 208, and/or the processor module232 of FIGS. 9-10, may comprise an image processor, image processingengine, media processor, or any specialized digital signal processor(DSP) used for the processing of digital images. The image processor mayemploy parallel computing with single instruction, multiple data (SIMD)or multiple instruction, multiple data (MIMD) technologies to increasespeed and efficiency. The digital image processing engine can perform arange of tasks. The image processor may be a system on a chip withmulticore processor architecture.

The communication connection(s) refers to the hardware/software employedto connect the network interface to the bus. While the communicationconnection is shown for illustrative clarity inside the computer system,it can also be external to the computer system 210. Thehardware/software necessary for connection to the network interfaceincludes, for illustrative purposes only, internal and externaltechnologies such as modems, including regular telephone-grade modems,cable modems, and DSL modems, ISDN adapters, and Ethernet cards.

FIG. 11 illustrates a functional block diagram of one aspect of a USBnetwork hub 300 device, according to one aspect of the presentdisclosure. In the illustrated aspect, the USB network hub device 300employs a TUSB2036 integrated circuit hub by Texas Instruments. The USBnetwork hub 300 is a CMOS device that provides an upstream USBtransceiver port 302 and up to three downstream USB transceiver ports304, 306, 308 in compliance with the USB 2.0 specification. The upstreamUSB transceiver port 302 is a differential root data port comprising adifferential data minus (DM0) input paired with a differential data plus(DP0) input. The three downstream USB transceiver ports 304, 306, 308are differential data ports where each port includes differential dataplus (DP1-DP3) outputs paired with differential data minus (DM1-DM3)outputs.

The USB network hub 300 device is implemented with a digital statemachine instead of a microcontroller, and no firmware programming isrequired. Fully compliant USB transceivers are integrated into thecircuit for the upstream USB transceiver port 302 and all downstream USBtransceiver ports 304, 306, 308. The downstream USB transceiver ports304, 306, 308 support both full-speed and low-speed devices byautomatically setting the slew rate according to the speed of the deviceattached to the ports. The USB network hub 300 device may be configuredeither in bus-powered or self-powered mode and includes a hub powerlogic 312 to manage power.

The USB network hub 300 device includes a serial interface engine 310(SIE). The SIE 310 is the front end of the USB network hub 300 hardwareand handles most of the protocol described in chapter 8 of the USBspecification. The SIE 310 typically comprehends signaling up to thetransaction level. The functions that it handles could include: packetrecognition, transaction sequencing, SOP, EOP, RESET, and RESUME signaldetection/generation, clock/data separation, non-return-to-zero invert(NRZI) data encoding/decoding and bit-stuffing, CRC generation andchecking (token and data), packet ID (PID) generation andchecking/decoding, and/or serial-parallel/parallel-serial conversion.The 310 receives a clock input 314 and is coupled to a suspend/resumelogic and frame timer 316 circuit and a hub repeater circuit 318 tocontrol communication between the upstream USB transceiver port 302 andthe downstream USB transceiver ports 304, 306, 308 through port logiccircuits 320, 322, 324. The SIE 310 is coupled to a command decoder 326via interface logic to control commands from a serial EEPROM via aserial EEPROM interface 330.

In various aspects, the USB network hub 300 can connect 127 functionsconfigured in up to six logical layers (tiers) to a single computer.Further, the USB network hub 300 can connect to all peripherals using astandardized four-wire cable that provides both communication and powerdistribution. The power configurations are bus-powered and self-poweredmodes. The USB network hub 300 may be configured to support four modesof power management: a bus-powered hub, with either individual-portpower management or ganged-port power management, and the self-poweredhub, with either individual-port power management or ganged-port powermanagement. In one aspect, using a USB cable, the USB network hub 300,the upstream USB transceiver port 302 is plugged into a USB hostcontroller, and the downstream USB transceiver ports 304, 306, 308 areexposed for connecting USB compatible devices, and so forth.

Surgical Instrument Hardware

FIG. 12 illustrates a logic diagram of a control system 470 of asurgical instrument or tool in accordance with one or more aspects ofthe present disclosure. The system 470 comprises a control circuit. Thecontrol circuit includes a microcontroller 461 comprising a processor462 and a memory 468. One or more of sensors 472, 474, 476, for example,provide real-time feedback to the processor 462. A motor 482, driven bya motor driver 492, operably couples a longitudinally movabledisplacement member to drive the I-beam knife element. A tracking system480 is configured to determine the position of the longitudinallymovable displacement member. The position information is provided to theprocessor 462, which can be programmed or configured to determine theposition of the longitudinally movable drive member as well as theposition of a firing member, firing bar, and I-beam knife element.Additional motors may be provided at the tool driver interface tocontrol I-beam firing, closure tube travel, shaft rotation, andarticulation. A display 473 displays a variety of operating conditionsof the instruments and may include touch screen functionality for datainput. Information displayed on the display 473 may be overlaid withimages acquired via endoscopic imaging modules.

In one aspect, the microcontroller 461 may be any single-core ormulticore processor such as those known under the trade name ARM Cortexby Texas Instruments. In one aspect, the main microcontroller 461 may bean LM4F230H5QR ARM Cortex-M4F Processor Core, available from TexasInstruments, for example, comprising an on-chip memory of 256 KBsingle-cycle flash memory, or other non-volatile memory, up to 40 MHz, aprefetch buffer to improve performance above 40 MHz, a 32 KBsingle-cycle SRAM, and internal ROM loaded with StellarisWare® software,a 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, and/orone or more 12-bit ADCs with 12 analog input channels, details of whichare available for the product datasheet.

In one aspect, the microcontroller 461 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The microcontroller 461 may be programmed to perform various functionssuch as precise control over the speed and position of the knife andarticulation systems. In one aspect, the microcontroller 461 includes aprocessor 462 and a memory 468. The electric motor 482 may be a brusheddirect current (DC) motor with a gearbox and mechanical links to anarticulation or knife system. In one aspect, a motor driver 492 may bean A3941 available from Allegro Microsystems, Inc. Other motor driversmay be readily substituted for use in the tracking system 480 comprisingan absolute positioning system. A detailed description of an absolutepositioning system is described in U.S. Patent Application PublicationNo. 2017/0296213, titled SYSTEMS AND METHODS FOR CONTROLLING A SURGICALSTAPLING AND CUTTING INSTRUMENT, which published on Oct. 19, 2017, whichis herein incorporated by reference in its entirety.

The microcontroller 461 may be programmed to provide precise controlover the speed and position of displacement members and articulationsystems. The microcontroller 461 may be configured to compute a responsein the software of the microcontroller 461. The computed response iscompared to a measured response of the actual system to obtain an“observed” response, which is used for actual feedback decisions. Theobserved response is a favorable, tuned value that balances the smooth,continuous nature of the simulated response with the measured response,which can detect outside influences on the system.

In one aspect, the motor 482 may be controlled by the motor driver 492and can be employed by the firing system of the surgical instrument ortool. In various forms, the motor 482 may be a brushed DC driving motorhaving a maximum rotational speed of approximately 25,000 RPM. In otherarrangements, the motor 482 may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The motor driver 492 may comprise an H-bridge drivercomprising field-effect transistors (FETs), for example. The motor 482can be powered by a power assembly releasably mounted to the handleassembly or tool housing for supplying control power to the surgicalinstrument or tool. The power assembly may comprise a battery which mayinclude a number of battery cells connected in series that can be usedas the power source to power the surgical instrument or tool. In certaincircumstances, the battery cells of the power assembly may bereplaceable and/or rechargeable. In at least one example, the batterycells can be lithium-ion batteries which can be couplable to andseparable from the power assembly.

The motor driver 492 may be an A3941 available from AllegroMicrosystems, Inc. The A3941 492 is a full-bridge controller for usewith external N-channel power metal-oxide semiconductor field-effecttransistors (MOSFETs) specifically designed for inductive loads, such asbrush DC motors. The driver 492 comprises a unique charge pump regulatorthat provides full (>10 V) gate drive for battery voltages down to 7 Vand allows the A3941 to operate with a reduced gate drive, down to 5.5V. A bootstrap capacitor may be employed to provide the above batterysupply voltage required for N-channel MOSFETs. An internal charge pumpfor the high-side drive allows DC (100% duty cycle) operation. The fullbridge can be driven in fast or slow decay modes using diode orsynchronous rectification. In the slow decay mode, current recirculationcan be through the high-side or the lowside FETs. The power FETs areprotected from shoot-through by resistor-adjustable dead time.Integrated diagnostics provide indications of undervoltage,overtemperature, and power bridge faults and can be configured toprotect the power MOSFETs under most short circuit conditions. Othermotor drivers may be readily substituted for use in the tracking system480 comprising an absolute positioning system.

The tracking system 480 comprises a controlled motor drive circuitarrangement comprising a position sensor 472 according to one aspect ofthis disclosure. The position sensor 472 for an absolute positioningsystem provides a unique position signal corresponding to the locationof a displacement member. In one aspect, the displacement memberrepresents a longitudinally movable drive member comprising a rack ofdrive teeth for meshing engagement with a corresponding drive gear of agear reducer assembly. In other aspects, the displacement memberrepresents the firing member, which could be adapted and configured toinclude a rack of drive teeth. In yet another aspect, the displacementmember represents a firing bar or the I-beam, each of which can beadapted and configured to include a rack of drive teeth. Accordingly, asused herein, the term displacement member is used generically to referto any movable member of the surgical instrument or tool such as thedrive member, the firing member, the firing bar, the I-beam, or anyelement that can be displaced. In one aspect, the longitudinally movabledrive member is coupled to the firing member, the firing bar, and theI-beam. Accordingly, the absolute positioning system can, in effect,track the linear displacement of the I-beam by tracking the lineardisplacement of the longitudinally movable drive member. In variousother aspects, the displacement member may be coupled to any positionsensor 472 suitable for measuring linear displacement. Thus, thelongitudinally movable drive member, the firing member, the firing bar,or the I-beam, or combinations thereof, may be coupled to any suitablelinear displacement sensor. Linear displacement sensors may includecontact or non-contact displacement sensors. Linear displacement sensorsmay comprise linear variable differential transformers (LVDT),differential variable reluctance transducers (DVRT), a slidepotentiometer, a magnetic sensing system comprising a movable magnet anda series of linearly arranged Hall effect sensors, a magnetic sensingsystem comprising a fixed magnet and a series of movable, linearlyarranged Hall effect sensors, an optical sensing system comprising amovable light source and a series of linearly arranged photo diodes orphoto detectors, an optical sensing system comprising a fixed lightsource and a series of movable linearly, arranged photo diodes or photodetectors, or any combination thereof.

The electric motor 482 can include a rotatable shaft that operablyinterfaces with a gear assembly that is mounted in meshing engagementwith a set, or rack, of drive teeth on the displacement member. A sensorelement may be operably coupled to a gear assembly such that a singlerevolution of the position sensor 472 element corresponds to some linearlongitudinal translation of the displacement member. An arrangement ofgearing and sensors can be connected to the linear actuator, via a rackand pinion arrangement, or a rotary actuator, via a spur gear or otherconnection. A power source supplies power to the absolute positioningsystem and an output indicator may display the output of the absolutepositioning system. The displacement member represents thelongitudinally movable drive member comprising a rack of drive teethformed thereon for meshing engagement with a corresponding drive gear ofthe gear reducer assembly. The displacement member represents thelongitudinally movable firing member, firing bar, I-beam, orcombinations thereof.

A single revolution of the sensor element associated with the positionsensor 472 is equivalent to a longitudinal linear displacement d1 of theof the displacement member, where d1 is the longitudinal linear distancethat the displacement member moves from point “a” to point “b” after asingle revolution of the sensor element coupled to the displacementmember. The sensor arrangement may be connected via a gear reductionthat results in the position sensor 472 completing one or morerevolutions for the full stroke of the displacement member. The positionsensor 472 may complete multiple revolutions for the full stroke of thedisplacement member.

A series of switches, where n is an integer greater than one, may beemployed alone or in combination with a gear reduction to provide aunique position signal for more than one revolution of the positionsensor 472. The state of the switches are fed back to themicrocontroller 461 that applies logic to determine a unique positionsignal corresponding to the longitudinal linear displacement d1+d2+ . .. dn of the displacement member. The output of the position sensor 472is provided to the microcontroller 461. The position sensor 472 of thesensor arrangement may comprise a magnetic sensor, an analog rotarysensor like a potentiometer, or an array of analog Hall-effect elements,which output a unique combination of position signals or values.

The position sensor 472 may comprise any number of magnetic sensingelements, such as, for example, magnetic sensors classified according towhether they measure the total magnetic field or the vector componentsof the magnetic field. The techniques used to produce both types ofmagnetic sensors encompass many aspects of physics and electronics. Thetechnologies used for magnetic field sensing include search coil,fluxgate, optically pumped, nuclear precession, SQUID, Hall-effect,anisotropic magnetoresistance, giant magnetoresistance, magnetic tunneljunctions, giant magnetoimpedance, magnetostrictive/piezoelectriccomposites, magnetodiode, magnetotransistor, fiber-optic, magneto-optic,and microelectromechanical systems-based magnetic sensors, among others.

In one aspect, the position sensor 472 for the tracking system 480comprising an absolute positioning system comprises a magnetic rotaryabsolute positioning system. The position sensor 472 may be implementedas an AS5055EQFT single-chip magnetic rotary position sensor availablefrom Austria Microsystems, AG. The position sensor 472 is interfacedwith the microcontroller 461 to provide an absolute positioning system.The position sensor 472 is a low-voltage and low-power component andincludes four Hall-effect elements in an area of the position sensor 472that is located above a magnet. A high-resolution ADC and a smart powermanagement controller are also provided on the chip. A coordinaterotation digital computer (CORDIC) processor, also known as thedigit-by-digit method and Volder's algorithm, is provided to implement asimple and efficient algorithm to calculate hyperbolic and trigonometricfunctions that require only addition, subtraction, bitshift, and tablelookup operations. The angle position, alarm bits, and magnetic fieldinformation are transmitted over a standard serial communicationinterface, such as a serial peripheral interface (SPI) interface, to themicrocontroller 461. The position sensor 472 provides 12 or 14 bits ofresolution. The position sensor 472 may be an AS5055 chip provided in asmall QFN 16-pin 4×4×0.85 mm package.

The tracking system 480 comprising an absolute positioning system maycomprise and/or be programmed to implement a feedback controller, suchas a PID, state feedback, and adaptive controller. A power sourceconverts the signal from the feedback controller into a physical inputto the system: in this case the voltage. Other examples include a PWM ofthe voltage, current, and force. Other sensor(s) may be provided tomeasure physical parameters of the physical system in addition to theposition measured by the position sensor 472. In some aspects, the othersensor(s) can include sensor arrangements such as those described inU.S. Pat. No. 9,345,481, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSORSYSTEM, which issued on May 24, 2016, which is herein incorporated byreference in its entirety; U.S. Patent Application Publication No.2014/0263552, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM,which published on Sep. 18, 2014, which is herein incorporated byreference in its entirety; and U.S. Pat. No. 10,881,399, titledTECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLINGAND CUTTING INSTRUMENT, which issued on Jan. 5, 2021, which is hereinincorporated by reference in its entirety. In a digital signalprocessing system, an absolute positioning system is coupled to adigital data acquisition system where the output of the absolutepositioning system will have a finite resolution and sampling frequency.The absolute positioning system may comprise a compare-and-combinecircuit to combine a computed response with a measured response usingalgorithms, such as a weighted average and a theoretical control loop,that drive the computed response towards the measured response. Thecomputed response of the physical system takes into account propertieslike mass, inertial, viscous friction, inductance resistance, etc., topredict what the states and outputs of the physical system will be byknowing the input.

The absolute positioning system provides an absolute position of thedisplacement member upon power-up of the instrument, without retractingor advancing the displacement member to a reset (zero or home) positionas may be required with conventional rotary encoders that merely countthe number of steps forwards or backwards that the motor 482 has takento infer the position of a device actuator, drive bar, knife, or thelike.

A sensor 474, such as, for example, a strain gauge or a micro-straingauge, is configured to measure one or more parameters of the endeffector, such as, for example, the amplitude of the strain exerted onthe anvil during a clamping operation, which can be indicative of theclosure forces applied to the anvil. The measured strain is converted toa digital signal and provided to the processor 462. Alternatively, or inaddition to the sensor 474, a sensor 476, such as, for example, a loadsensor, can measure the closure force applied by the closure drivesystem to the anvil. The sensor 476, such as, for example, a loadsensor, can measure the firing force applied to an I-beam in a firingstroke of the surgical instrument or tool. The I-beam is configured toengage a wedge sled, which is configured to upwardly cam staple driversto force out staples into deforming contact with an anvil. The I-beamalso includes a sharpened cutting edge that can be used to sever tissueas the I-beam is advanced distally by the firing bar. Alternatively, acurrent sensor 478 can be employed to measure the current drawn by themotor 482. The force required to advance the firing member cancorrespond to the current drawn by the motor 482, for example. Themeasured force is converted to a digital signal and provided to theprocessor 462.

In one form, the strain gauge sensor 474 can be used to measure theforce applied to the tissue by the end effector. A strain gauge can becoupled to the end effector to measure the force on the tissue beingtreated by the end effector. A system for measuring forces applied tothe tissue grasped by the end effector comprises a strain gauge sensor474, such as, for example, a micro-strain gauge, that is configured tomeasure one or more parameters of the end effector, for example. In oneaspect, the strain gauge sensor 474 can measure the amplitude ormagnitude of the strain exerted on a jaw member of an end effectorduring a clamping operation, which can be indicative of the tissuecompression. The measured strain is converted to a digital signal andprovided to a processor 462 of the microcontroller 461. A load sensor476 can measure the force used to operate the knife element, forexample, to cut the tissue captured between the anvil and the staplecartridge. A magnetic field sensor can be employed to measure thethickness of the captured tissue. The measurement of the magnetic fieldsensor also may be converted to a digital signal and provided to theprocessor 462.

The measurements of the tissue compression, the tissue thickness, and/orthe force required to close the end effector on the tissue, asrespectively measured by the sensors 474, 476, can be used by themicrocontroller 461 to characterize the selected position of the firingmember and/or the corresponding value of the speed of the firing member.In one instance, a memory 468 may store a technique, an equation, and/ora lookup table which can be employed by the microcontroller 461 in theassessment.

The control system 470 of the surgical instrument or tool also maycomprise wired or wireless communication circuits to communicate withthe modular communication hub as shown in FIGS. 8-11.

FIG. 13 illustrates a control circuit 500 configured to control aspectsof the surgical instrument or tool according to one aspect of thisdisclosure. The control circuit 500 can be configured to implementvarious processes described herein. The control circuit 500 may comprisea microcontroller comprising one or more processors 502 (e.g.,microprocessor, microcontroller) coupled to at least one memory circuit504. The memory circuit 504 stores machine-executable instructions that,when executed by the processor 502, cause the processor 502 to executemachine instructions to implement various processes described herein.The processor 502 may be any one of a number of single-core or multicoreprocessors known in the art. The memory circuit 504 may comprisevolatile and non-volatile storage media. The processor 502 may includean instruction processing unit 506 and an arithmetic unit 508. Theinstruction processing unit may be configured to receive instructionsfrom the memory circuit 504 of this disclosure.

FIG. 14 illustrates a combinational logic circuit 510 configured tocontrol aspects of the surgical instrument or tool according to oneaspect of this disclosure. The combinational logic circuit 510 can beconfigured to implement various processes described herein. Thecombinational logic circuit 510 may comprise a finite state machinecomprising a combinational logic 512 configured to receive dataassociated with the surgical instrument or tool at an input 514, processthe data by the combinational logic 512, and provide an output 516.

FIG. 15 illustrates a sequential logic circuit 520 configured to controlaspects of the surgical instrument or tool according to one aspect ofthis disclosure. The sequential logic circuit 520 or the combinationallogic 522 can be configured to implement various processes describedherein. The sequential logic circuit 520 may comprise a finite statemachine. The sequential logic circuit 520 may comprise a combinationallogic 522, at least one memory circuit 524, and a clock 529, forexample. The at least one memory circuit 524 can store a current stateof the finite state machine. In certain instances, the sequential logiccircuit 520 may be synchronous or asynchronous. The combinational logic522 is configured to receive data associated with the surgicalinstrument or tool from an input 526, process the data by thecombinational logic 522, and provide an output 528. In other aspects,the circuit may comprise a combination of a processor (e.g., processor502, FIG. 13) and a finite state machine to implement various processesherein. In other aspects, the finite state machine may comprise acombination of a combinational logic circuit (e.g., combinational logiccircuit 510, FIG. 14) and the sequential logic circuit 520.

FIG. 16 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions. Incertain instances, a first motor can be activated to perform a firstfunction, a second motor can be activated to perform a second function,a third motor can be activated to perform a third function, a fourthmotor can be activated to perform a fourth function, and so on. Incertain instances, the plurality of motors of robotic surgicalinstrument 600 can be individually activated to cause firing, closure,and/or articulation motions in the end effector. The firing, closure,and/or articulation motions can be transmitted to the end effectorthrough a shaft assembly, for example.

In certain instances, the surgical instrument system or tool may includea firing motor 602. The firing motor 602 may be operably coupled to afiring motor drive assembly 604 which can be configured to transmitfiring motions, generated by the motor 602 to the end effector, inparticular to displace the I-beam element. In certain instances, thefiring motions generated by the motor 602 may cause the staples to bedeployed from the staple cartridge into tissue captured by the endeffector and/or the cutting edge of the I-beam element to be advanced tocut the captured tissue, for example. The I-beam element may beretracted by reversing the direction of the motor 602.

In certain instances, the surgical instrument or tool may include aclosure motor 603. The closure motor 603 may be operably coupled to aclosure motor drive assembly 605 which can be configured to transmitclosure motions, generated by the motor 603 to the end effector, inparticular to displace a closure tube to close the anvil and compresstissue between the anvil and the staple cartridge. The closure motionsmay cause the end effector to transition from an open configuration toan approximated configuration to capture tissue, for example. The endeffector may be transitioned to an open position by reversing thedirection of the motor 603.

In certain instances, the surgical instrument or tool may include one ormore articulation motors 606 a, 606 b, for example. The motors 606 a,606 b may be operably coupled to respective articulation motor driveassemblies 608 a, 608 b, which can be configured to transmitarticulation motions generated by the motors 606 a, 606 b to the endeffector. In certain instances, the articulation motions may cause theend effector to articulate relative to the shaft, for example.

As described above, the surgical instrument or tool may include aplurality of motors which may be configured to perform variousindependent functions. In certain instances, the plurality of motors ofthe surgical instrument or tool can be individually or separatelyactivated to perform one or more functions while the other motors remaininactive. For example, the articulation motors 606 a, 606 b can beactivated to cause the end effector to be articulated while the firingmotor 602 remains inactive. Alternatively, the firing motor 602 can beactivated to fire the plurality of staples, and/or to advance thecutting edge, while the articulation motor 606 remains inactive.Furthermore the closure motor 603 may be activated simultaneously withthe firing motor 602 to cause the closure tube and the I-beam element toadvance distally as described in more detail hereinbelow.

In certain instances, the surgical instrument or tool may include acommon control module 610 which can be employed with a plurality ofmotors of the surgical instrument or tool. In certain instances, thecommon control module 610 may accommodate one of the plurality of motorsat a time. For example, the common control module 610 can be couplableto and separable from the plurality of motors of the robotic surgicalinstrument individually. In certain instances, a plurality of the motorsof the surgical instrument or tool may share one or more common controlmodules such as the common control module 610. In certain instances, aplurality of motors of the surgical instrument or tool can beindividually and selectively engaged with the common control module 610.In certain instances, the common control module 610 can be selectivelyswitched from interfacing with one of a plurality of motors of thesurgical instrument or tool to interfacing with another one of theplurality of motors of the surgical instrument or tool.

In at least one example, the common control module 610 can beselectively switched between operable engagement with the articulationmotors 606 a, 606 b and operable engagement with either the firing motor602 or the closure motor 603. In at least one example, as illustrated inFIG. 16, a switch 614 can be moved or transitioned between a pluralityof positions and/or states. In a first position 616, the switch 614 mayelectrically couple the common control module 610 to the firing motor602; in a second position 617, the switch 614 may electrically couplethe common control module 610 to the closure motor 603; in a thirdposition 618 a, the switch 614 may electrically couple the commoncontrol module 610 to the first articulation motor 606 a; and in afourth position 618 b, the switch 614 may electrically couple the commoncontrol module 610 to the second articulation motor 606 b, for example.In certain instances, separate common control modules 610 can beelectrically coupled to the firing motor 602, the closure motor 603, andthe articulations motor 606 a, 606 b at the same time. In certaininstances, the switch 614 may be a mechanical switch, anelectromechanical switch, a solid-state switch, or any suitableswitching mechanism.

Each of the motors 602, 603, 606 a, 606 b may comprise a torque sensorto measure the output torque on the shaft of the motor. The force on anend effector may be sensed in any conventional manner, such as by forcesensors on the outer sides of the jaws or by a torque sensor for themotor actuating the jaws.

In various instances, as illustrated in FIG. 16, the common controlmodule 610 may comprise a motor driver 626 which may comprise one ormore H-Bridge FETs. The motor driver 626 may modulate the powertransmitted from a power source 628 to a motor coupled to the commoncontrol module 610 based on input from a microcontroller 620 (the“controller”), for example. In certain instances, the microcontroller620 can be employed to determine the current drawn by the motor, forexample, while the motor is coupled to the common control module 610, asdescribed above.

In certain instances, the microcontroller 620 may include amicroprocessor 622 (the “processor”) and one or more non-transitorycomputer-readable mediums or memory units 624 (the “memory”). In certaininstances, the memory 624 may store various program instructions, whichwhen executed may cause the processor 622 to perform a plurality offunctions and/or calculations described herein. In certain instances,one or more of the memory units 624 may be coupled to the processor 622,for example.

In certain instances, the power source 628 can be employed to supplypower to the microcontroller 620, for example. In certain instances, thepower source 628 may comprise a battery (or “battery pack” or “powerpack”), such as a lithium-ion battery, for example. In certaininstances, the battery pack may be configured to be releasably mountedto a handle for supplying power to the surgical instrument 600. A numberof battery cells connected in series may be used as the power source628. In certain instances, the power source 628 may be replaceableand/or rechargeable, for example.

In various instances, the processor 622 may control the motor driver 626to control the position, direction of rotation, and/or velocity of amotor that is coupled to the common control module 610. In certaininstances, the processor 622 can signal the motor driver 626 to stopand/or disable a motor that is coupled to the common control module 610.It should be understood that the term “processor” as used hereinincludes any suitable microprocessor, microcontroller, or other basiccomputing device that incorporates the functions of a computer's centralprocessing unit (CPU) on an integrated circuit or, at most, a fewintegrated circuits. The processor is a multipurpose, programmabledevice that accepts digital data as input, processes it according toinstructions stored in its memory, and provides results as output. It isan example of sequential digital logic, as it has internal memory.Processors operate on numbers and symbols represented in the binarynumeral system.

In one instance, the processor 622 may be any single-core or multicoreprocessor such as those known under the trade name ARM Cortex by TexasInstruments. In certain instances, the microcontroller 620 may be an LM4F230H5QR, available from Texas Instruments, for example. In at leastone example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4FProcessor Core comprising an on-chip memory of 256 KB single-cycle flashmemory, or other non-volatile memory, up to 40 MHz, a prefetch buffer toimprove performance above 40 MHz, a 32 KB single-cycle SRAM, an internalROM loaded with StellarisWare® software, a 2 KB EEPROM, one or more PWMmodules, one or more QEI analogs, one or more 12-bit ADCs with 12 analoginput channels, among other features that are readily available for theproduct datasheet. Other microcontrollers may be readily substituted foruse with the module 4410. Accordingly, the present disclosure should notbe limited in this context.

In certain instances, the memory 624 may include program instructionsfor controlling each of the motors of the surgical instrument 600 thatare couplable to the common control module 610. For example, the memory624 may include program instructions for controlling the firing motor602, the closure motor 603, and the articulation motors 606 a, 606 b.Such program instructions may cause the processor 622 to control thefiring, closure, and articulation functions in accordance with inputsfrom algorithms or control programs of the surgical instrument or tool.

In certain instances, one or more mechanisms and/or sensors such as, forexample, sensors 630 can be employed to alert the processor 622 to theprogram instructions that should be used in a particular setting. Forexample, the sensors 630 may alert the processor 622 to use the programinstructions associated with firing, closing, and articulating the endeffector. In certain instances, the sensors 630 may comprise positionsensors which can be employed to sense the position of the switch 614,for example. Accordingly, the processor 622 may use the programinstructions associated with firing the I-beam of the end effector upondetecting, through the sensors 630 for example, that the switch 614 isin the first position 616; the processor 622 may use the programinstructions associated with closing the anvil upon detecting, throughthe sensors 630 for example, that the switch 614 is in the secondposition 617; and the processor 622 may use the program instructionsassociated with articulating the end effector upon detecting, throughthe sensors 630 for example, that the switch 614 is in the third orfourth position 618 a, 618 b.

FIG. 17 is a schematic diagram of a robotic surgical instrument 700configured to operate a surgical tool described herein according to oneaspect of this disclosure. The robotic surgical instrument 700 may beprogrammed or configured to control distal/proximal translation of adisplacement member, distal/proximal displacement of a closure tube,shaft rotation, and articulation, either with single or multiplearticulation drive links. In one aspect, the surgical instrument 700 maybe programmed or configured to individually control a firing member, aclosure member, a shaft member, and/or one or more articulation members.The surgical instrument 700 comprises a control circuit 710 configuredto control motor-driven firing members, closure members, shaft members,and/or one or more articulation members.

In one aspect, the robotic surgical instrument 700 comprises a controlcircuit 710 configured to control an anvil 716 and an I-beam 714(including a sharp cutting edge) portion of an end effector 702, aremovable staple cartridge 718, a shaft 740, and one or morearticulation members 742 a, 742 b via a plurality of motors 704 a-704 e.A position sensor 734 may be configured to provide position feedback ofthe I-beam 714 to the control circuit 710. Other sensors 738 may beconfigured to provide feedback to the control circuit 710. Atimer/counter 731 provides timing and counting information to thecontrol circuit 710. An energy source 712 may be provided to operate themotors 704 a-704 e, and a current sensor 736 provides motor currentfeedback to the control circuit 710. The motors 704 a-704 e can beoperated individually by the control circuit 710 in a open-loop orclosed-loop feedback control.

In one aspect, the control circuit 710 may comprise one or moremicrocontrollers, microprocessors, or other suitable processors forexecuting instructions that cause the processor or processors to performone or more tasks. In one aspect, a timer/counter 731 provides an outputsignal, such as the elapsed time or a digital count, to the controlcircuit 710 to correlate the position of the I-beam 714 as determined bythe position sensor 734 with the output of the timer/counter 731 suchthat the control circuit 710 can determine the position of the I-beam714 at a specific time (t) relative to a starting position or the time(t) when the I-beam 714 is at a specific position relative to a startingposition. The timer/counter 731 may be configured to measure elapsedtime, count external events, or time external events.

In one aspect, the control circuit 710 may be programmed to controlfunctions of the end effector 702 based on one or more tissueconditions. The control circuit 710 may be programmed to sense tissueconditions, such as thickness, either directly or indirectly, asdescribed herein. The control circuit 710 may be programmed to select afiring control program or closure control program based on tissueconditions. A firing control program may describe the distal motion ofthe displacement member. Different firing control programs may beselected to better treat different tissue conditions. For example, whenthicker tissue is present, the control circuit 710 may be programmed totranslate the displacement member at a lower velocity and/or with lowerpower. When thinner tissue is present, the control circuit 710 may beprogrammed to translate the displacement member at a higher velocityand/or with higher power. A closure control program may control theclosure force applied to the tissue by the anvil 716. Other controlprograms control the rotation of the shaft 740 and the articulationmembers 742 a, 742 b.

In one aspect, the control circuit 710 may generate motor set pointsignals. The motor set point signals may be provided to various motorcontrollers 708 a-708 e. The motor controllers 708 a-708 e may compriseone or more circuits configured to provide motor drive signals to themotors 704 a-704 e to drive the motors 704 a-704 e as described herein.In some examples, the motors 704 a-704 e may be brushed DC electricmotors. For example, the velocity of the motors 704 a-704 e may beproportional to the respective motor drive signals. In some examples,the motors 704 a-704 e may be brushless DC electric motors, and therespective motor drive signals may comprise a PWM signal provided to oneor more stator windings of the motors 704 a-704 e. Also, in someexamples, the motor controllers 708 a-708 e may be omitted and thecontrol circuit 710 may generate the motor drive signals directly.

In one aspect, the control circuit 710 may initially operate each of themotors 704 a-704 e in an open-loop configuration for a first open-loopportion of a stroke of the displacement member. Based on the response ofthe robotic surgical instrument 700 during the open-loop portion of thestroke, the control circuit 710 may select a firing control program in aclosed-loop configuration. The response of the instrument may include atranslation distance of the displacement member during the open-loopportion, a time elapsed during the open-loop portion, the energyprovided to one of the motors 704 a-704 e during the open-loop portion,a sum of pulse widths of a motor drive signal, etc. After the open-loopportion, the control circuit 710 may implement the selected firingcontrol program for a second portion of the displacement member stroke.For example, during a closed-loop portion of the stroke, the controlcircuit 710 may modulate one of the motors 704 a-704 e based ontranslation data describing a position of the displacement member in aclosed-loop manner to translate the displacement member at a constantvelocity.

In one aspect, the motors 704 a-704 e may receive power from an energysource 712. The energy source 712 may be a DC power supply driven by amain alternating current power source, a battery, a super capacitor, orany other suitable energy source. The motors 704 a-704 e may bemechanically coupled to individual movable mechanical elements such asthe I-beam 714, anvil 716, shaft 740, articulation 742 a, andarticulation 742 b via respective transmissions 706 a-706 e. Thetransmissions 706 a-706 e may include one or more gears or other linkagecomponents to couple the motors 704 a-704 e to movable mechanicalelements. A position sensor 734 may sense a position of the I-beam 714.The position sensor 734 may be or include any type of sensor that iscapable of generating position data that indicate a position of theI-beam 714. In some examples, the position sensor 734 may include anencoder configured to provide a series of pulses to the control circuit710 as the I-beam 714 translates distally and proximally. The controlcircuit 710 may track the pulses to determine the position of the I-beam714. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 714. Also, in someexamples, the position sensor 734 may be omitted. Where any of themotors 704 a-704 e is a stepper motor, the control circuit 710 may trackthe position of the I-beam 714 by aggregating the number and directionof steps that the motor 704 has been instructed to execute. The positionsensor 734 may be located in the end effector 702 or at any otherportion of the instrument. The outputs of each of the motors 704 a-704 einclude a torque sensor 744 a-744 e to sense force and have an encoderto sense rotation of the drive shaft.

In one aspect, the control circuit 710 is configured to drive a firingmember such as the I-beam 714 portion of the end effector 702. Thecontrol circuit 710 provides a motor set point to a motor control 708 a,which provides a drive signal to the motor 704 a. The output shaft ofthe motor 704 a is coupled to a torque sensor 744 a. The torque sensor744 a is coupled to a transmission 706 a which is coupled to the I-beam714. The transmission 706 a comprises movable mechanical elements suchas rotating elements and a firing member to control the movement of theI-beam 714 distally and proximally along a longitudinal axis of the endeffector 702. In one aspect, the motor 704 a may be coupled to the knifegear assembly, which includes a knife gear reduction set that includes afirst knife drive gear and a second knife drive gear. A torque sensor744 a provides a firing force feedback signal to the control circuit710. The firing force signal represents the force required to fire ordisplace the I-beam 714. A position sensor 734 may be configured toprovide the position of the I-beam 714 along the firing stroke or theposition of the firing member as a feedback signal to the controlcircuit 710. The end effector 702 may include additional sensors 738configured to provide feedback signals to the control circuit 710. Whenready to use, the control circuit 710 may provide a firing signal to themotor control 708 a. In response to the firing signal, the motor 704 amay drive the firing member distally along the longitudinal axis of theend effector 702 from a proximal stroke start position to a stroke endposition distal to the stroke start position. As the firing membertranslates distally, an I-beam 714, with a cutting element positioned ata distal end, advances distally to cut tissue located between the staplecartridge 718 and the anvil 716.

In one aspect, the control circuit 710 is configured to drive a closuremember such as the anvil 716 portion of the end effector 702. Thecontrol circuit 710 provides a motor set point to a motor control 708 b,which provides a drive signal to the motor 704 b. The output shaft ofthe motor 704 b is coupled to a torque sensor 744 b. The torque sensor744 b is coupled to a transmission 706 b which is coupled to the anvil716. The transmission 706 b comprises movable mechanical elements suchas rotating elements and a closure member to control the movement of theanvil 716 from the open and closed positions. In one aspect, the motor704 b is coupled to a closure gear assembly, which includes a closurereduction gear set that is supported in meshing engagement with theclosure spur gear. The torque sensor 744 b provides a closure forcefeedback signal to the control circuit 710. The closure force feedbacksignal represents the closure force applied to the anvil 716. Theposition sensor 734 may be configured to provide the position of theclosure member as a feedback signal to the control circuit 710.Additional sensors 738 in the end effector 702 may provide the closureforce feedback signal to the control circuit 710. The pivotable anvil716 is positioned opposite the staple cartridge 718. When ready to use,the control circuit 710 may provide a closure signal to the motorcontrol 708 b. In response to the closure signal, the motor 704 badvances a closure member to grasp tissue between the anvil 716 and thestaple cartridge 718.

In one aspect, the control circuit 710 is configured to rotate a shaftmember such as the shaft 740 to rotate the end effector 702. The controlcircuit 710 provides a motor set point to a motor control 708 c, whichprovides a drive signal to the motor 704 c. The output shaft of themotor 704 c is coupled to a torque sensor 744 c. The torque sensor 744 cis coupled to a transmission 706 c which is coupled to the shaft 740.The transmission 706 c comprises movable mechanical elements such asrotating elements to control the rotation of the shaft 740 clockwise orcounterclockwise up to and over 360°. In one aspect, the motor 704 c iscoupled to the rotational transmission assembly, which includes a tubegear segment that is formed on (or attached to) the proximal end of theproximal closure tube for operable engagement by a rotational gearassembly that is operably supported on the tool mounting plate. Thetorque sensor 744 c provides a rotation force feedback signal to thecontrol circuit 710. The rotation force feedback signal represents therotation force applied to the shaft 740. The position sensor 734 may beconfigured to provide the position of the closure member as a feedbacksignal to the control circuit 710. Additional sensors 738 such as ashaft encoder may provide the rotational position of the shaft 740 tothe control circuit 710.

In one aspect, the control circuit 710 is configured to articulate theend effector 702. The control circuit 710 provides a motor set point toa motor control 708 d, which provides a drive signal to the motor 704 d.The output shaft of the motor 704 d is coupled to a torque sensor 744 d.The torque sensor 744 d is coupled to a transmission 706 d which iscoupled to an articulation member 742 a. The transmission 706 dcomprises movable mechanical elements such as articulation elements tocontrol the articulation of the end effector 702±65°. In one aspect, themotor 704 d is coupled to an articulation nut, which is rotatablyjournaled on the proximal end portion of the distal spine portion and isrotatably driven thereon by an articulation gear assembly. The torquesensor 744 d provides an articulation force feedback signal to thecontrol circuit 710. The articulation force feedback signal representsthe articulation force applied to the end effector 702. Sensors 738,such as an articulation encoder, may provide the articulation positionof the end effector 702 to the control circuit 710.

In another aspect, the articulation function of the robotic surgicalsystem 700 may comprise two articulation members, or links, 742 a, 742b. These articulation members 742 a, 742 b are driven by separate diskson the robot interface (the rack) which are driven by the two motors 708d, 708 e. When the separate firing motor 704 a is provided, each ofarticulation links 742 a, 742 b can be antagonistically driven withrespect to the other link in order to provide a resistive holding motionand a load to the head when it is not moving and to provide anarticulation motion as the head is articulated. The articulation members742 a, 742 b attach to the head at a fixed radius as the head isrotated. Accordingly, the mechanical advantage of the push-and-pull linkchanges as the head is rotated. This change in the mechanical advantagemay be more pronounced with other articulation link drive systems.

In one aspect, the one or more motors 704 a-704 e may comprise a brushedDC motor with a gearbox and mechanical links to a firing member, closuremember, or articulation member. Another example includes electric motors704 a-704 e that operate the movable mechanical elements such as thedisplacement member, articulation links, closure tube, and shaft. Anoutside influence is an unmeasured, unpredictable influence of thingslike tissue, surrounding bodies, and friction on the physical system.Such outside influence can be referred to as drag, which acts inopposition to one of electric motors 704 a-704 e. The outside influence,such as drag, may cause the operation of the physical system to deviatefrom a desired operation of the physical system.

In one aspect, the position sensor 734 may be implemented as an absolutepositioning system. In one aspect, the position sensor 734 may comprisea magnetic rotary absolute positioning system implemented as anAS5055EQFT single-chip magnetic rotary position sensor available fromAustria Microsystems, AG. The position sensor 734 may interface with thecontrol circuit 710 to provide an absolute positioning system. Theposition may include multiple Hall-effect elements located above amagnet and coupled to a CORDIC processor, also known as thedigit-by-digit method and Volder's algorithm, that is provided toimplement a simple and efficient algorithm to calculate hyperbolic andtrigonometric functions that require only addition, subtraction,bitshift, and table lookup operations.

In one aspect, the control circuit 710 may be in communication with oneor more sensors 738. The sensors 738 may be positioned on the endeffector 702 and adapted to operate with the robotic surgical instrument700 to measure the various derived parameters such as the gap distanceversus time, tissue compression versus time, and anvil strain versustime. The sensors 738 may comprise a magnetic sensor, a magnetic fieldsensor, a strain gauge, a load cell, a pressure sensor, a force sensor,a torque sensor, an inductive sensor such as an eddy current sensor, aresistive sensor, a capacitive sensor, an optical sensor, and/or anyother suitable sensor for measuring one or more parameters of the endeffector 702. The sensors 738 may include one or more sensors. Thesensors 738 may be located on the staple cartridge 718 deck to determinetissue location using segmented electrodes. The torque sensors 744 a-744e may be configured to sense force such as firing force, closure force,and/or articulation force, among others. Accordingly, the controlcircuit 710 can sense (1) the closure load experienced by the distalclosure tube and its position, (2) the firing member at the rack and itsposition, (3) what portion of the staple cartridge 718 has tissue on it,and (4) the load and position on both articulation rods.

In one aspect, the one or more sensors 738 may comprise a strain gauge,such as a micro-strain gauge, configured to measure the magnitude of thestrain in the anvil 716 during a clamped condition. The strain gaugeprovides an electrical signal whose amplitude varies with the magnitudeof the strain. The sensors 738 may comprise a pressure sensor configuredto detect a pressure generated by the presence of compressed tissuebetween the anvil 716 and the staple cartridge 718. The sensors 738 maybe configured to detect impedance of a tissue section located betweenthe anvil 716 and the staple cartridge 718 that is indicative of thethickness and/or fullness of tissue located therebetween.

In one aspect, the sensors 738 may be implemented as one or more limitswitches, electromechanical devices, solid-state switches, Hall-effectdevices, magneto-resistive (MR) devices, giant magneto-resistive (GMR)devices, magnetometers, among others. In other implementations, thesensors 738 may be implemented as solid-state switches that operateunder the influence of light, such as optical sensors, IR sensors,ultraviolet sensors, among others. Still, the switches may besolid-state devices such as transistors (e.g., FET, junction FET,MOSFET, bipolar, and the like). In other implementations, the sensors738 may include electrical conductorless switches, ultrasonic switches,accelerometers, and inertial sensors, among others.

In one aspect, the sensors 738 may be configured to measure forcesexerted on the anvil 716 by the closure drive system. For example, oneor more sensors 738 can be at an interaction point between the closuretube and the anvil 716 to detect the closure forces applied by theclosure tube to the anvil 716. The forces exerted on the anvil 716 canbe representative of the tissue compression experienced by the tissuesection captured between the anvil 716 and the staple cartridge 718. Theone or more sensors 738 can be positioned at various interaction pointsalong the closure drive system to detect the closure forces applied tothe anvil 716 by the closure drive system. The one or more sensors 738may be sampled in real time during a clamping operation by the processorof the control circuit 710. The control circuit 710 receives real-timesample measurements to provide and analyze time-based information andassess, in real time, closure forces applied to the anvil 716.

In one aspect, a current sensor 736 can be employed to measure thecurrent drawn by each of the motors 704 a-704 e. The force required toadvance any of the movable mechanical elements such as the I-beam 714corresponds to the current drawn by one of the motors 704 a-704 e. Theforce is converted to a digital signal and provided to the controlcircuit 710. The control circuit 710 can be configured to simulate theresponse of the actual system of the instrument in the software of thecontroller. A displacement member can be actuated to move an I-beam 714in the end effector 702 at or near a target velocity. The roboticsurgical instrument 700 can include a feedback controller, which can beone of any feedback controllers, including, but not limited to a PID, astate feedback, a linear-quadratic (LQR), and/or an adaptive controller,for example. The robotic surgical instrument 700 can include a powersource to convert the signal from the feedback controller into aphysical input such as case voltage, PWM voltage, frequency modulatedvoltage, current, torque, and/or force, for example. Additional detailsare disclosed in U.S. Pat. No. 10,932,772, titled CLOSED LOOP VELOCITYCONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT, which issued on Mar.2, 2021, which is herein incorporated by reference in its entirety.

FIG. 18 illustrates a block diagram of a surgical instrument 750programmed to control the distal translation of a displacement memberaccording to one aspect of this disclosure. In one aspect, the surgicalinstrument 750 is programmed to control the distal translation of adisplacement member such as the I-beam 764. The surgical instrument 750comprises an end effector 752 that may comprise an anvil 766, an I-beam764 (including a sharp cutting edge), and a removable staple cartridge768.

The position, movement, displacement, and/or translation of a lineardisplacement member, such as the I-beam 764, can be measured by anabsolute positioning system, sensor arrangement, and position sensor784. Because the I-beam 764 is coupled to a longitudinally movable drivemember, the position of the I-beam 764 can be determined by measuringthe position of the longitudinally movable drive member employing theposition sensor 784. Accordingly, in the following description, theposition, displacement, and/or translation of the I-beam 764 can beachieved by the position sensor 784 as described herein. A controlcircuit 760 may be programmed to control the translation of thedisplacement member, such as the I-beam 764. The control circuit 760, insome examples, may comprise one or more microcontrollers,microprocessors, or other suitable processors for executing instructionsthat cause the processor or processors to control the displacementmember, e.g., the I-beam 764, in the manner described. In one aspect, atimer/counter 781 provides an output signal, such as the elapsed time ora digital count, to the control circuit 760 to correlate the position ofthe I-beam 764 as determined by the position sensor 784 with the outputof the timer/counter 781 such that the control circuit 760 can determinethe position of the I-beam 764 at a specific time (t) relative to astarting position. The timer/counter 781 may be configured to measureelapsed time, count external events, or time external events.

The control circuit 760 may generate a motor set point signal 772. Themotor set point signal 772 may be provided to a motor controller 758.The motor controller 758 may comprise one or more circuits configured toprovide a motor drive signal 774 to the motor 754 to drive the motor 754as described herein. In some examples, the motor 754 may be a brushed DCelectric motor. For example, the velocity of the motor 754 may beproportional to the motor drive signal 774. In some examples, the motor754 may be a brushless DC electric motor and the motor drive signal 774may comprise a PWM signal provided to one or more stator windings of themotor 754. Also, in some examples, the motor controller 758 may beomitted, and the control circuit 760 may generate the motor drive signal774 directly.

The motor 754 may receive power from an energy source 762. The energysource 762 may be or include a battery, a super capacitor, or any othersuitable energy source. The motor 754 may be mechanically coupled to theI-beam 764 via a transmission 756. The transmission 756 may include oneor more gears or other linkage components to couple the motor 754 to theI-beam 764. A position sensor 784 may sense a position of the I-beam764. The position sensor 784 may be or include any type of sensor thatis capable of generating position data that indicate a position of theI-beam 764. In some examples, the position sensor 784 may include anencoder configured to provide a series of pulses to the control circuit760 as the I-beam 764 translates distally and proximally. The controlcircuit 760 may track the pulses to determine the position of the I-beam764. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 764. Also, in someexamples, the position sensor 784 may be omitted. Where the motor 754 isa stepper motor, the control circuit 760 may track the position of theI-beam 764 by aggregating the number and direction of steps that themotor 754 has been instructed to execute. The position sensor 784 may belocated in the end effector 752 or at any other portion of theinstrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 752 andadapted to operate with the surgical instrument 750 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 752. The sensors 788 may include one ormore sensors.

The one or more sensors 788 may comprise a strain gauge, such as amicro-strain gauge, configured to measure the magnitude of the strain inthe anvil 766 during a clamped condition. The strain gauge provides anelectrical signal whose amplitude varies with the magnitude of thestrain. The sensors 788 may comprise a pressure sensor configured todetect a pressure generated by the presence of compressed tissue betweenthe anvil 766 and the staple cartridge 768. The sensors 788 may beconfigured to detect impedance of a tissue section located between theanvil 766 and the staple cartridge 768 that is indicative of thethickness and/or fullness of tissue located therebetween.

The sensors 788 may be is configured to measure forces exerted on theanvil 766 by a closure drive system. For example, one or more sensors788 can be at an interaction point between a closure tube and the anvil766 to detect the closure forces applied by a closure tube to the anvil766. The forces exerted on the anvil 766 can be representative of thetissue compression experienced by the tissue section captured betweenthe anvil 766 and the staple cartridge 768. The one or more sensors 788can be positioned at various interaction points along the closure drivesystem to detect the closure forces applied to the anvil 766 by theclosure drive system. The one or more sensors 788 may be sampled in realtime during a clamping operation by a processor of the control circuit760. The control circuit 760 receives real-time sample measurements toprovide and analyze time-based information and assess, in real time,closure forces applied to the anvil 766.

A current sensor 786 can be employed to measure the current drawn by themotor 754. The force required to advance the I-beam 764 corresponds tothe current drawn by the motor 754. The force is converted to a digitalsignal and provided to the control circuit 760.

The control circuit 760 can be configured to simulate the response ofthe actual system of the instrument in the software of the controller. Adisplacement member can be actuated to move an I-beam 764 in the endeffector 752 at or near a target velocity. The surgical instrument 750can include a feedback controller, which can be one of any feedbackcontrollers, including, but not limited to a PID, a state feedback, LQR,and/or an adaptive controller, for example. The surgical instrument 750can include a power source to convert the signal from the feedbackcontroller into a physical input such as case voltage, PWM voltage,frequency modulated voltage, current, torque, and/or force, for example.

The actual drive system of the surgical instrument 750 is configured todrive the displacement member, cutting member, or I-beam 764, by abrushed DC motor with gearbox and mechanical links to an articulationand/or knife system. Another example is the electric motor 754 thatoperates the displacement member and the articulation driver, forexample, of an interchangeable shaft assembly. An outside influence isan unmeasured, unpredictable influence of things like tissue,surrounding bodies and friction on the physical system. Such outsideinfluence can be referred to as drag which acts in opposition to theelectric motor 754. The outside influence, such as drag, may cause theoperation of the physical system to deviate from a desired operation ofthe physical system.

Various example aspects are directed to a surgical instrument 750comprising an end effector 752 with motor-driven surgical stapling andcutting implements. For example, a motor 754 may drive a displacementmember distally and proximally along a longitudinal axis of the endeffector 752. The end effector 752 may comprise a pivotable anvil 766and, when configured for use, a staple cartridge 768 positioned oppositethe anvil 766. A clinician may grasp tissue between the anvil 766 andthe staple cartridge 768, as described herein. When ready to use theinstrument 750, the clinician may provide a firing signal, for exampleby depressing a trigger of the instrument 750. In response to the firingsignal, the motor 754 may drive the displacement member distally alongthe longitudinal axis of the end effector 752 from a proximal strokebegin position to a stroke end position distal of the stroke beginposition. As the displacement member translates distally, an I-beam 764with a cutting element positioned at a distal end, may cut the tissuebetween the staple cartridge 768 and the anvil 766.

In various examples, the surgical instrument 750 may comprise a controlcircuit 760 programmed to control the distal translation of thedisplacement member, such as the I-beam 764, for example, based on oneor more tissue conditions. The control circuit 760 may be programmed tosense tissue conditions, such as thickness, either directly orindirectly, as described herein. The control circuit 760 may beprogrammed to select a firing control program based on tissueconditions. A firing control program may describe the distal motion ofthe displacement member. Different firing control programs may beselected to better treat different tissue conditions. For example, whenthicker tissue is present, the control circuit 760 may be programmed totranslate the displacement member at a lower velocity and/or with lowerpower. When thinner tissue is present, the control circuit 760 may beprogrammed to translate the displacement member at a higher velocityand/or with higher power.

In some examples, the control circuit 760 may initially operate themotor 754 in an open loop configuration for a first open loop portion ofa stroke of the displacement member. Based on a response of theinstrument 750 during the open loop portion of the stroke, the controlcircuit 760 may select a firing control program. The response of theinstrument may include, a translation distance of the displacementmember during the open loop portion, a time elapsed during the open loopportion, energy provided to the motor 754 during the open loop portion,a sum of pulse widths of a motor drive signal, etc. After the open loopportion, the control circuit 760 may implement the selected firingcontrol program for a second portion of the displacement member stroke.For example, during the closed loop portion of the stroke, the controlcircuit 760 may modulate the motor 754 based on translation datadescribing a position of the displacement member in a closed loop mannerto translate the displacement member at a constant velocity. Additionaldetails are disclosed in U.S. Pat. No. 10,743,872, titled SYSTEM ANDMETHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT, which issuedon Aug. 18, 2020, which is herein incorporated by reference in itsentirety.

FIG. 19 is a schematic diagram of a surgical instrument 790 configuredto control various functions according to one aspect of this disclosure.In one aspect, the surgical instrument 790 is programmed to controldistal translation of a displacement member such as the I-beam 764. Thesurgical instrument 790 comprises an end effector 792 that may comprisean anvil 766, an I-beam 764, and a removable staple cartridge 768 whichmay be interchanged with an RF cartridge 796 (shown in dashed line).

In one aspect, sensors 788 may be implemented as a limit switch,electromechanical device, solid-state switches, Hall-effect devices, MRdevices, GMR devices, magnetometers, among others. In otherimplementations, the sensors 638 may be solid-state switches thatoperate under the influence of light, such as optical sensors, IRsensors, ultraviolet sensors, among others. Still, the switches may besolid-state devices such as transistors (e.g., FET, junction FET,MOSFET, bipolar, and the like). In other implementations, the sensors788 may include electrical conductorless switches, ultrasonic switches,accelerometers, and inertial sensors, among others.

In one aspect, the position sensor 784 may be implemented as an absolutepositioning system comprising a magnetic rotary absolute positioningsystem implemented as an AS5055EQFT single-chip magnetic rotary positionsensor available from Austria Microsystems, AG. The position sensor 784may interface with the control circuit 760 to provide an absolutepositioning system. The position may include multiple Hall-effectelements located above a magnet and coupled to a CORDIC processor, alsoknown as the digit-by-digit method and Volder's algorithm, that isprovided to implement a simple and efficient algorithm to calculatehyperbolic and trigonometric functions that require only addition,subtraction, bitshift, and table lookup operations.

In one aspect, the I-beam 764 may be implemented as a knife membercomprising a knife body that operably supports a tissue cutting bladethereon and may further include anvil engagement tabs or features andchannel engagement features or a foot. In one aspect, the staplecartridge 768 may be implemented as a standard (mechanical) surgicalfastener cartridge. In one aspect, the RF cartridge 796 may beimplemented as an RF cartridge. These and other sensors arrangements aredescribed in commonly owned U.S. Pat. No. 10,881,399, titled TECHNIQUESFOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING ANDCUTTING INSTRUMENT, which issued on Jan. 5, 2021, which is hereinincorporated by reference in its entirety.

The position, movement, displacement, and/or translation of a lineardisplacement member, such as the I-beam 764, can be measured by anabsolute positioning system, sensor arrangement, and position sensorrepresented as position sensor 784. Because the I-beam 764 is coupled tothe longitudinally movable drive member, the position of the I-beam 764can be determined by measuring the position of the longitudinallymovable drive member employing the position sensor 784. Accordingly, inthe following description, the position, displacement, and/ortranslation of the I-beam 764 can be achieved by the position sensor 784as described herein. A control circuit 760 may be programmed to controlthe translation of the displacement member, such as the I-beam 764, asdescribed herein. The control circuit 760, in some examples, maycomprise one or more microcontrollers, microprocessors, or othersuitable processors for executing instructions that cause the processoror processors to control the displacement member, e.g., the I-beam 764,in the manner described. In one aspect, a timer/counter 781 provides anoutput signal, such as the elapsed time or a digital count, to thecontrol circuit 760 to correlate the position of the I-beam 764 asdetermined by the position sensor 784 with the output of thetimer/counter 781 such that the control circuit 760 can determine theposition of the I-beam 764 at a specific time (t) relative to a startingposition. The timer/counter 781 may be configured to measure elapsedtime, count external events, or time external events.

The control circuit 760 may generate a motor set point signal 772. Themotor set point signal 772 may be provided to a motor controller 758.The motor controller 758 may comprise one or more circuits configured toprovide a motor drive signal 774 to the motor 754 to drive the motor 754as described herein. In some examples, the motor 754 may be a brushed DCelectric motor. For example, the velocity of the motor 754 may beproportional to the motor drive signal 774. In some examples, the motor754 may be a brushless DC electric motor and the motor drive signal 774may comprise a PWM signal provided to one or more stator windings of themotor 754. Also, in some examples, the motor controller 758 may beomitted, and the control circuit 760 may generate the motor drive signal774 directly.

The motor 754 may receive power from an energy source 762. The energysource 762 may be or include a battery, a super capacitor, or any othersuitable energy source. The motor 754 may be mechanically coupled to theI-beam 764 via a transmission 756. The transmission 756 may include oneor more gears or other linkage components to couple the motor 754 to theI-beam 764. A position sensor 784 may sense a position of the I-beam764. The position sensor 784 may be or include any type of sensor thatis capable of generating position data that indicate a position of theI-beam 764. In some examples, the position sensor 784 may include anencoder configured to provide a series of pulses to the control circuit760 as the I-beam 764 translates distally and proximally. The controlcircuit 760 may track the pulses to determine the position of the I-beam764. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 764. Also, in someexamples, the position sensor 784 may be omitted. Where the motor 754 isa stepper motor, the control circuit 760 may track the position of theI-beam 764 by aggregating the number and direction of steps that themotor has been instructed to execute. The position sensor 784 may belocated in the end effector 792 or at any other portion of theinstrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 792 andadapted to operate with the surgical instrument 790 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 792. The sensors 788 may include one ormore sensors.

The one or more sensors 788 may comprise a strain gauge, such as amicro-strain gauge, configured to measure the magnitude of the strain inthe anvil 766 during a clamped condition. The strain gauge provides anelectrical signal whose amplitude varies with the magnitude of thestrain. The sensors 788 may comprise a pressure sensor configured todetect a pressure generated by the presence of compressed tissue betweenthe anvil 766 and the staple cartridge 768. The sensors 788 may beconfigured to detect impedance of a tissue section located between theanvil 766 and the staple cartridge 768 that is indicative of thethickness and/or fullness of tissue located therebetween.

The sensors 788 may be is configured to measure forces exerted on theanvil 766 by the closure drive system. For example, one or more sensors788 can be at an interaction point between a closure tube and the anvil766 to detect the closure forces applied by a closure tube to the anvil766. The forces exerted on the anvil 766 can be representative of thetissue compression experienced by the tissue section captured betweenthe anvil 766 and the staple cartridge 768. The one or more sensors 788can be positioned at various interaction points along the closure drivesystem to detect the closure forces applied to the anvil 766 by theclosure drive system. The one or more sensors 788 may be sampled in realtime during a clamping operation by a processor portion of the controlcircuit 760. The control circuit 760 receives real-time samplemeasurements to provide and analyze time-based information and assess,in real time, closure forces applied to the anvil 766.

A current sensor 786 can be employed to measure the current drawn by themotor 754. The force required to advance the I-beam 764 corresponds tothe current drawn by the motor 754. The force is converted to a digitalsignal and provided to the control circuit 760.

An RF energy source 794 is coupled to the end effector 792 and isapplied to the RF cartridge 796 when the RF cartridge 796 is loaded inthe end effector 792 in place of the staple cartridge 768. The controlcircuit 760 controls the delivery of the RF energy to the RF cartridge796.

Additional details are disclosed in U.S. Patent Application PublicationNo. 2019/0000478, titled SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGEAND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME, which publishedon Jan. 3, 2019, which is herein incorporated by reference in itsentirety.

Generator Hardware

FIG. 20 is a simplified block diagram of a generator 800 configured toprovide inductorless tuning, among other benefits. Additional details ofthe generator 800 are described in U.S. Pat. No. 9,060,775, titledSURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSURGICAL DEVICES, whichissued on Jun. 23, 2015, which is herein incorporated by reference inits entirety. The generator 800 may comprise a patient isolated stage802 in communication with a non-isolated stage 804 via a powertransformer 806. A secondary winding 808 of the power transformer 806 iscontained in the isolated stage 802 and may comprise a tappedconfiguration (e.g., a center-tapped or a non-center-tappedconfiguration) to define drive signal outputs 810 a, 810 b, 810 c fordelivering drive signals to different surgical instruments, such as, forexample, an ultrasonic surgical instrument, an RF electrosurgicalinstrument, and a multifunction surgical instrument which includesultrasonic and RF energy modes that can be delivered alone orsimultaneously. In particular, drive signal outputs 810 a, 810 c mayoutput an ultrasonic drive signal (e.g., a 420V root-mean-square (RMS)drive signal) to an ultrasonic surgical instrument, and drive signaloutputs 810 b, 810 c may output an RF electrosurgical drive signal(e.g., a 100V RMS drive signal) to an RF electrosurgical instrument,with the drive signal output 810 b corresponding to the center tap ofthe power transformer 806.

In certain forms, the ultrasonic and electrosurgical drive signals maybe provided simultaneously to distinct surgical instruments and/or to asingle surgical instrument, such as the multifunction surgicalinstrument, having the capability to deliver both ultrasonic andelectrosurgical energy to tissue. It will be appreciated that theelectrosurgical signal, provided either to a dedicated electrosurgicalinstrument and/or to a combined multifunction ultrasonic/electrosurgicalinstrument may be either a therapeutic or sub-therapeutic level signalwhere the sub-therapeutic signal can be used, for example, to monitortissue or instrument conditions and provide feedback to the generator.For example, the ultrasonic and RF signals can be delivered separatelyor simultaneously from a generator with a single output port in order toprovide the desired output signal to the surgical instrument, as will bediscussed in more detail below. Accordingly, the generator can combinethe ultrasonic and electrosurgical RF energies and deliver the combinedenergies to the multifunction ultrasonic/electrosurgical instrument.Bipolar electrodes can be placed on one or both jaws of the endeffector. One jaw may be driven by ultrasonic energy in addition toelectrosurgical RF energy, working simultaneously. The ultrasonic energymay be employed to dissect tissue, while the electrosurgical RF energymay be employed for vessel sealing.

The non-isolated stage 804 may comprise a power amplifier 812 having anoutput connected to a primary winding 814 of the power transformer 806.In certain forms, the power amplifier 812 may comprise a push-pullamplifier. For example, the non-isolated stage 804 may further comprisea logic device 816 for supplying a digital output to a digital-to-analogconverter (DAC) circuit 818, which in turn supplies a correspondinganalog signal to an input of the power amplifier 812. In certain forms,the logic device 816 may comprise a programmable gate array (PGA), aFPGA, programmable logic device (PLD), among other logic circuits, forexample. The logic device 816, by virtue of controlling the input of thepower amplifier 812 via the DAC circuit 818, may therefore control anyof a number of parameters (e.g., frequency, waveform shape, waveformamplitude) of drive signals appearing at the drive signal outputs 810 a,810 b, 810 c. In certain forms and as discussed below, the logic device816, in conjunction with a processor (e.g., a DSP discussed below), mayimplement a number of DSP-based and/or other control algorithms tocontrol parameters of the drive signals output by the generator 800.

Power may be supplied to a power rail of the power amplifier 812 by aswitch-mode regulator 820, e.g., a power converter. In certain forms,the switch-mode regulator 820 may comprise an adjustable buck regulator,for example. The non-isolated stage 804 may further comprise a firstprocessor 822, which in one form may comprise a DSP processor such as anAnalog Devices ADSP-21469 SHARC DSP, available from Analog Devices,Norwood, Mass., for example, although in various forms any suitableprocessor may be employed. In certain forms the DSP processor 822 maycontrol the operation of the switch-mode regulator 820 responsive tovoltage feedback data received from the power amplifier 812 by the DSPprocessor 822 via an ADC circuit 824. In one form, for example, the DSPprocessor 822 may receive as input, via the ADC circuit 824, thewaveform envelope of a signal (e.g., an RF signal) being amplified bythe power amplifier 812. The DSP processor 822 may then control theswitch-mode regulator 820 (e.g., via a PWM output) such that the railvoltage supplied to the power amplifier 812 tracks the waveform envelopeof the amplified signal. By dynamically modulating the rail voltage ofthe power amplifier 812 based on the waveform envelope, the efficiencyof the power amplifier 812 may be significantly improved relative to afixed rail voltage amplifier schemes.

In certain forms, the logic device 816, in conjunction with the DSPprocessor 822, may implement a digital synthesis circuit such as adirect digital synthesizer control scheme to control the waveform shape,frequency, and/or amplitude of drive signals output by the generator800. In one form, for example, the logic device 816 may implement a DDScontrol algorithm by recalling waveform samples stored in a dynamicallyupdated lookup table (LUT), such as a RAM LUT, which may be embedded inan FPGA. This control algorithm is particularly useful for ultrasonicapplications in which an ultrasonic transducer, such as an ultrasonictransducer, may be driven by a clean sinusoidal current at its resonantfrequency. Because other frequencies may excite parasitic resonances,minimizing or reducing the total distortion of the motional branchcurrent may correspondingly minimize or reduce undesirable resonanceeffects. Because the waveform shape of a drive signal output by thegenerator 800 is impacted by various sources of distortion present inthe output drive circuit (e.g., the power transformer 806, the poweramplifier 812), voltage and current feedback data based on the drivesignal may be input into an algorithm, such as an error controlalgorithm implemented by the DSP processor 822, which compensates fordistortion by suitably pre-distorting or modifying the waveform samplesstored in the LUT on a dynamic, ongoing basis (e.g., in real time). Inone form, the amount or degree of pre-distortion applied to the LUTsamples may be based on the error between a computed motional branchcurrent and a desired current waveform shape, with the error beingdetermined on a sample-by-sample basis. In this way, the pre-distortedLUT samples, when processed through the drive circuit, may result in amotional branch drive signal having the desired waveform shape (e.g.,sinusoidal) for optimally driving the ultrasonic transducer. In suchforms, the LUT waveform samples will therefore not represent the desiredwaveform shape of the drive signal, but rather the waveform shape thatis required to ultimately produce the desired waveform shape of themotional branch drive signal when distortion effects are taken intoaccount.

The non-isolated stage 804 may further comprise a first ADC circuit 826and a second ADC circuit 828 coupled to the output of the powertransformer 806 via respective isolation transformers 830, 832 forrespectively sampling the voltage and current of drive signals output bythe generator 800. In certain forms, the ADC circuits 826, 828 may beconfigured to sample at high speeds (e.g., 80 mega samples per second(MSPS)) to enable oversampling of the drive signals. In one form, forexample, the sampling speed of the ADC circuits 826, 828 may enableapproximately 200× (depending on frequency) oversampling of the drivesignals. In certain forms, the sampling operations of the ADC circuit826, 828 may be performed by a single ADC circuit receiving inputvoltage and current signals via a two-way multiplexer. The use ofhigh-speed sampling in forms of the generator 800 may enable, amongother things, calculation of the complex current flowing through themotional branch (which may be used in certain forms to implementDDS-based waveform shape control described above), accurate digitalfiltering of the sampled signals, and calculation of real powerconsumption with a high degree of precision. Voltage and currentfeedback data output by the ADC circuits 826, 828 may be received andprocessed (e.g., first-in-first-out (FIFO) buffer, multiplexer) by thelogic device 816 and stored in data memory for subsequent retrieval by,for example, the DSP processor 822. As noted above, voltage and currentfeedback data may be used as input to an algorithm for pre-distorting ormodifying LUT waveform samples on a dynamic and ongoing basis. Incertain forms, this may require each stored voltage and current feedbackdata pair to be indexed based on, or otherwise associated with, acorresponding LUT sample that was output by the logic device 816 whenthe voltage and current feedback data pair was acquired. Synchronizationof the LUT samples and the voltage and current feedback data in thismanner contributes to the correct timing and stability of thepre-distortion algorithm.

In certain forms, the voltage and current feedback data may be used tocontrol the frequency and/or amplitude (e.g., current amplitude) of thedrive signals. In one form, for example, voltage and current feedbackdata may be used to determine impedance phase. The frequency of thedrive signal may then be controlled to minimize or reduce the differencebetween the determined impedance phase and an impedance phase setpoint(e.g., 0°), thereby minimizing or reducing the effects of harmonicdistortion and correspondingly enhancing impedance phase measurementaccuracy. The determination of phase impedance and a frequency controlsignal may be implemented in the DSP processor 822, for example, withthe frequency control signal being supplied as input to a DDS controlalgorithm implemented by the logic device 816.

In another form, for example, the current feedback data may be monitoredin order to maintain the current amplitude of the drive signal at acurrent amplitude setpoint. The current amplitude setpoint may bespecified directly or determined indirectly based on specified voltageamplitude and power setpoints. In certain forms, control of the currentamplitude may be implemented by control algorithm, such as, for example,a proportional-integral-derivative (PID) control algorithm, in the DSPprocessor 822. Variables controlled by the control algorithm to suitablycontrol the current amplitude of the drive signal may include, forexample, the scaling of the LUT waveform samples stored in the logicdevice 816 and/or the full-scale output voltage of the DAC circuit 818(which supplies the input to the power amplifier 812) via a DAC circuit834.

The non-isolated stage 804 may further comprise a second processor 836for providing, among other things user interface (UI) functionality. Inone form, the UI processor 836 may comprise an Atmel AT91SAM9263processor having an ARM 926EJ-S core, available from Atmel Corporation,San Jose, Calif., for example. Examples of UI functionality supported bythe UI processor 836 may include audible and visual user feedback,communication with peripheral devices (e.g., via a USB interface),communication with a foot switch, communication with an input device(e.g., a touch screen display) and communication with an output device(e.g., a speaker). The UI processor 836 may communicate with the DSPprocessor 822 and the logic device 816 (e.g., via SPI buses). Althoughthe UI processor 836 may primarily support UI functionality, it may alsocoordinate with the DSP processor 822 to implement hazard mitigation incertain forms. For example, the UI processor 836 may be programmed tomonitor various aspects of user input and/or other inputs (e.g., touchscreen inputs, foot switch inputs, temperature sensor inputs) and maydisable the drive output of the generator 800 when an erroneouscondition is detected.

In certain forms, both the DSP processor 822 and the UI processor 836,for example, may determine and monitor the operating state of thegenerator 800. For the DSP processor 822, the operating state of thegenerator 800 may dictate, for example, which control and/or diagnosticprocesses are implemented by the DSP processor 822. For the UI processor836, the operating state of the generator 800 may dictate, for example,which elements of a UI (e.g., display screens, sounds) are presented toa user. The respective DSP and UI processors 822, 836 may independentlymaintain the current operating state of the generator 800 and recognizeand evaluate possible transitions out of the current operating state.The DSP processor 822 may function as the master in this relationshipand determine when transitions between operating states are to occur.The UI processor 836 may be aware of valid transitions between operatingstates and may confirm if a particular transition is appropriate. Forexample, when the DSP processor 822 instructs the UI processor 836 totransition to a specific state, the UI processor 836 may verify thatrequested transition is valid. In the event that a requested transitionbetween states is determined to be invalid by the UI processor 836, theUI processor 836 may cause the generator 800 to enter a failure mode.

The non-isolated stage 804 may further comprise a controller 838 formonitoring input devices (e.g., a capacitive touch sensor used forturning the generator 800 on and off, a capacitive touch screen). Incertain forms, the controller 838 may comprise at least one processorand/or other controller device in communication with the UI processor836. In one form, for example, the controller 838 may comprise aprocessor (e.g., a Meg168 8-bit controller available from Atmel)configured to monitor user input provided via one or more capacitivetouch sensors. In one form, the controller 838 may comprise a touchscreen controller (e.g., a QT5480 touch screen controller available fromAtmel) to control and manage the acquisition of touch data from acapacitive touch screen.

In certain forms, when the generator 800 is in a “power off” state, thecontroller 838 may continue to receive operating power (e.g., via a linefrom a power supply of the generator 800, such as the power supply 854discussed below). In this way, the controller 838 may continue tomonitor an input device (e.g., a capacitive touch sensor located on afront panel of the generator 800) for turning the generator 800 on andoff. When the generator 800 is in the power off state, the controller838 may wake the power supply (e.g., enable operation of one or moreDC/DC voltage converters 856 of the power supply 854) if activation ofthe “on/off” input device by a user is detected. The controller 838 maytherefore initiate a sequence for transitioning the generator 800 to a“power on” state. Conversely, the controller 838 may initiate a sequencefor transitioning the generator 800 to the power off state if activationof the “on/off” input device is detected when the generator 800 is inthe power on state. In certain forms, for example, the controller 838may report activation of the “on/off” input device to the UI processor836, which in turn implements the necessary process sequence fortransitioning the generator 800 to the power off state. In such forms,the controller 838 may have no independent ability for causing theremoval of power from the generator 800 after its power on state hasbeen established.

In certain forms, the controller 838 may cause the generator 800 toprovide audible or other sensory feedback for alerting the user that apower on or power off sequence has been initiated. Such an alert may beprovided at the beginning of a power on or power off sequence and priorto the commencement of other processes associated with the sequence.

In certain forms, the isolated stage 802 may comprise an instrumentinterface circuit 840 to, for example, provide a communication interfacebetween a control circuit of a surgical instrument (e.g., a controlcircuit comprising handpiece switches) and components of thenon-isolated stage 804, such as, for example, the logic device 816, theDSP processor 822, and/or the UI processor 836. The instrument interfacecircuit 840 may exchange information with components of the non-isolatedstage 804 via a communication link that maintains a suitable degree ofelectrical isolation between the isolated and non-isolated stages 802,804, such as, for example, an IR-based communication link. Power may besupplied to the instrument interface circuit 840 using, for example, alow-dropout voltage regulator powered by an isolation transformer drivenfrom the non-isolated stage 804.

In one form, the instrument interface circuit 840 may comprise a logiccircuit 842 (e.g., logic circuit, programmable logic circuit, PGA, FPGA,PLD) in communication with a signal conditioning circuit 844. The signalconditioning circuit 844 may be configured to receive a periodic signalfrom the logic circuit 842 (e.g., a 2 kHz square wave) to generate abipolar interrogation signal having an identical frequency. Theinterrogation signal may be generated, for example, using a bipolarcurrent source fed by a differential amplifier. The interrogation signalmay be communicated to a surgical instrument control circuit (e.g., byusing a conductive pair in a cable that connects the generator 800 tothe surgical instrument) and monitored to determine a state orconfiguration of the control circuit. The control circuit may comprise anumber of switches, resistors, and/or diodes to modify one or morecharacteristics (e.g., amplitude, rectification) of the interrogationsignal such that a state or configuration of the control circuit isuniquely discernable based on the one or more characteristics. In oneform, for example, the signal conditioning circuit 844 may comprise anADC circuit for generating samples of a voltage signal appearing acrossinputs of the control circuit resulting from passage of interrogationsignal therethrough. The logic circuit 842 (or a component of thenon-isolated stage 804) may then determine the state or configuration ofthe control circuit based on the ADC circuit samples.

In one form, the instrument interface circuit 840 may comprise a firstdata circuit interface 846 to enable information exchange between thelogic circuit 842 (or other element of the instrument interface circuit840) and a first data circuit disposed in or otherwise associated with asurgical instrument. In certain forms, for example, a first data circuitmay be disposed in a cable integrally attached to a surgical instrumenthandpiece or in an adaptor for interfacing a specific surgicalinstrument type or model with the generator 800. The first data circuitmay be implemented in any suitable manner and may communicate with thegenerator according to any suitable protocol, including, for example, asdescribed herein with respect to the first data circuit. In certainforms, the first data circuit may comprise a non-volatile storagedevice, such as an EEPROM device. In certain forms, the first datacircuit interface 846 may be implemented separately from the logiccircuit 842 and comprise suitable circuitry (e.g., discrete logicdevices, a processor) to enable communication between the logic circuit842 and the first data circuit. In other forms, the first data circuitinterface 846 may be integral with the logic circuit 842.

In certain forms, the first data circuit may store informationpertaining to the particular surgical instrument with which it isassociated. Such information may include, for example, a model number, aserial number, a number of operations in which the surgical instrumenthas been used, and/or any other type of information. This informationmay be read by the instrument interface circuit 840 (e.g., by the logiccircuit 842), transferred to a component of the non-isolated stage 804(e.g., to logic device 816, DSP processor 822, and/or UI processor 836)for presentation to a user via an output device and/or for controlling afunction or operation of the generator 800. Additionally, any type ofinformation may be communicated to the first data circuit for storagetherein via the first data circuit interface 846 (e.g., using the logiccircuit 842). Such information may comprise, for example, an updatednumber of operations in which the surgical instrument has been usedand/or dates and/or times of its usage.

As discussed previously, a surgical instrument may be detachable from ahandpiece (e.g., the multifunction surgical instrument may be detachablefrom the handpiece) to promote instrument interchangeability and/ordisposability. In such cases, conventional generators may be limited intheir ability to recognize particular instrument configurations beingused and to optimize control and diagnostic processes accordingly. Theaddition of readable data circuits to surgical instruments to addressthis issue is problematic from a compatibility standpoint, however. Forexample, designing a surgical instrument to remain backwardly compatiblewith generators that lack the requisite data reading functionality maybe impractical due to, for example, differing signal schemes, designcomplexity, and cost. Forms of instruments discussed herein addressthese concerns by using data circuits that may be implemented inexisting surgical instruments economically and with minimal designchanges to preserve compatibility of the surgical instruments withcurrent generator platforms.

Additionally, forms of the generator 800 may enable communication withinstrument-based data circuits. For example, the generator 800 may beconfigured to communicate with a second data circuit contained in aninstrument (e.g., the multifunction surgical instrument). In some forms,the second data circuit may be implemented in a many similar to that ofthe first data circuit described herein. The instrument interfacecircuit 840 may comprise a second data circuit interface 848 to enablethis communication. In one form, the second data circuit interface 848may comprise a tri-state digital interface, although other interfacesmay also be used. In certain forms, the second data circuit maygenerally be any circuit for transmitting and/or receiving data. In oneform, for example, the second data circuit may store informationpertaining to the particular surgical instrument with which it isassociated. Such information may include, for example, a model number, aserial number, a number of operations in which the surgical instrumenthas been used, and/or any other type of information.

In some forms, the second data circuit may store information about theelectrical and/or ultrasonic properties of an associated ultrasonictransducer, end effector, or ultrasonic drive system. For example, thefirst data circuit may indicate a burn-in frequency slope, as describedherein. Additionally or alternatively, any type of information may becommunicated to second data circuit for storage therein via the seconddata circuit interface 848 (e.g., using the logic circuit 842). Suchinformation may comprise, for example, an updated number of operationsin which the instrument has been used and/or dates and/or times of itsusage. In certain forms, the second data circuit may transmit dataacquired by one or more sensors (e.g., an instrument-based temperaturesensor). In certain forms, the second data circuit may receive data fromthe generator 800 and provide an indication to a user (e.g., a lightemitting diode indication or other visible indication) based on thereceived data.

In certain forms, the second data circuit and the second data circuitinterface 848 may be configured such that communication between thelogic circuit 842 and the second data circuit can be effected withoutthe need to provide additional conductors for this purpose (e.g.,dedicated conductors of a cable connecting a handpiece to the generator800). In one form, for example, information may be communicated to andfrom the second data circuit using a one-wire bus communication schemeimplemented on existing cabling, such as one of the conductors usedtransmit interrogation signals from the signal conditioning circuit 844to a control circuit in a handpiece. In this way, design changes ormodifications to the surgical instrument that might otherwise benecessary are minimized or reduced. Moreover, because different types ofcommunications implemented over a common physical channel can befrequency-band separated, the presence of a second data circuit may be“invisible” to generators that do not have the requisite data readingfunctionality, thus enabling backward compatibility of the surgicalinstrument.

In certain forms, the isolated stage 802 may comprise at least oneblocking capacitor 850-1 connected to the drive signal output 810 b toprevent passage of DC current to a patient. A single blocking capacitormay be required to comply with medical regulations or standards, forexample. While failure in single-capacitor designs is relativelyuncommon, such failure may nonetheless have negative consequences. Inone form, a second blocking capacitor 850-2 may be provided in serieswith the blocking capacitor 850-1, with current leakage from a pointbetween the blocking capacitors 850-1, 850-2 being monitored by, forexample, an ADC circuit 852 for sampling a voltage induced by leakagecurrent. The samples may be received by the logic circuit 842, forexample. Based changes in the leakage current (as indicated by thevoltage samples), the generator 800 may determine when at least one ofthe blocking capacitors 850-1, 850-2 has failed, thus providing abenefit over single-capacitor designs having a single point of failure.

In certain forms, the non-isolated stage 804 may comprise a power supply854 for delivering DC power at a suitable voltage and current. The powersupply may comprise, for example, a 400 W power supply for delivering a48 VDC system voltage. The power supply 854 may further comprise one ormore DC/DC voltage converters 856 for receiving the output of the powersupply to generate DC outputs at the voltages and currents required bythe various components of the generator 800. As discussed above inconnection with the controller 838, one or more of the DC/DC voltageconverters 856 may receive an input from the controller 838 whenactivation of the “on/off” input device by a user is detected by thecontroller 838 to enable operation of, or wake, the DC/DC voltageconverters 856.

FIG. 21 illustrates an example of a generator 900, which is one form ofthe generator 800 (FIG. 20). The generator 900 is configured to delivermultiple energy modalities to a surgical instrument. The generator 900provides RF and ultrasonic signals for delivering energy to a surgicalinstrument either independently or simultaneously. The RF and ultrasonicsignals may be provided alone or in combination and may be providedsimultaneously. As noted above, at least one generator output candeliver multiple energy modalities (e.g., ultrasonic, bipolar ormonopolar RF, irreversible and/or reversible electroporation, and/ormicrowave energy, among others) through a single port, and these signalscan be delivered separately or simultaneously to the end effector totreat tissue.

The generator 900 comprises a processor 902 coupled to a waveformgenerator 904. The processor 902 and waveform generator 904 areconfigured to generate a variety of signal waveforms based oninformation stored in a memory coupled to the processor 902, not shownfor clarity of disclosure. The digital information associated with awaveform is provided to the waveform generator 904 which includes one ormore DAC circuits to convert the digital input into an analog output.The analog output is fed to an amplifier 1106 for signal conditioningand amplification. The conditioned and amplified output of the amplifier906 is coupled to a power transformer 908. The signals are coupledacross the power transformer 908 to the secondary side, which is in thepatient isolation side. A first signal of a first energy modality isprovided to the surgical instrument between the terminals labeledENERGY1 and RETURN. A second signal of a second energy modality iscoupled across a capacitor 910 and is provided to the surgicalinstrument between the terminals labeled ENERGY2 and RETURN. It will beappreciated that more than two energy modalities may be output and thusthe subscript “n” may be used to designate that up to n ENERGYnterminals may be provided, where n is a positive integer greater than 1.It also will be appreciated that up to “n” return paths RETURNn may beprovided without departing from the scope of the present disclosure.

A first voltage sensing circuit 912 is coupled across the terminalslabeled ENERGY1 and the RETURN path to measure the output voltagetherebetween. A second voltage sensing circuit 924 is coupled across theterminals labeled ENERGY2 and the RETURN path to measure the outputvoltage therebetween. A current sensing circuit 914 is disposed inseries with the RETURN leg of the secondary side of the powertransformer 908 as shown to measure the output current for either energymodality. If different return paths are provided for each energymodality, then a separate current sensing circuit should be provided ineach return leg. The outputs of the first and second voltage sensingcircuits 912, 924 are provided to respective isolation transformers 916,922 and the output of the current sensing circuit 914 is provided toanother isolation transformer 918. The outputs of the isolationtransformers 916, 928, 922 in the on the primary side of the powertransformer 908 (non-patient isolated side) are provided to a one ormore ADC circuit 926. The digitized output of the ADC circuit 926 isprovided to the processor 902 for further processing and computation.The output voltages and output current feedback information can beemployed to adjust the output voltage and current provided to thesurgical instrument and to compute output impedance, among otherparameters. Input/output communications between the processor 902 andpatient isolated circuits is provided through an interface circuit 920.Sensors also may be in electrical communication with the processor 902by way of the interface circuit 920.

In one aspect, the impedance may be determined by the processor 902 bydividing the output of either the first voltage sensing circuit 912coupled across the terminals labeled ENERGY1/RETURN or the secondvoltage sensing circuit 924 coupled across the terminals labeledENERGY2/RETURN by the output of the current sensing circuit 914 disposedin series with the RETURN leg of the secondary side of the powertransformer 908. The outputs of the first and second voltage sensingcircuits 912, 924 are provided to separate isolations transformers 916,922 and the output of the current sensing circuit 914 is provided toanother isolation transformer 916. The digitized voltage and currentsensing measurements from the ADC circuit 926 are provided the processor902 for computing impedance. As an example, the first energy modalityENERGY1 may be ultrasonic energy and the second energy modality ENERGY2may be RF energy. Nevertheless, in addition to ultrasonic and bipolar ormonopolar RF energy modalities, other energy modalities includeirreversible and/or reversible electroporation and/or microwave energy,among others. Also, although the example illustrated in FIG. 21 shows asingle return path RETURN may be provided for two or more energymodalities, in other aspects, multiple return paths RETURNn may beprovided for each energy modality ENERGYn. Thus, as described herein,the ultrasonic transducer impedance may be measured by dividing theoutput of the first voltage sensing circuit 912 by the current sensingcircuit 914 and the tissue impedance may be measured by dividing theoutput of the second voltage sensing circuit 924 by the current sensingcircuit 914.

As shown in FIG. 21, the generator 900 comprising at least one outputport can include a power transformer 908 with a single output and withmultiple taps to provide power in the form of one or more energymodalities, such as ultrasonic, bipolar or monopolar RF, irreversibleand/or reversible electroporation, and/or microwave energy, amongothers, for example, to the end effector depending on the type oftreatment of tissue being performed. For example, the generator 900 candeliver energy with higher voltage and lower current to drive anultrasonic transducer, with lower voltage and higher current to drive RFelectrodes for sealing tissue, or with a coagulation waveform for spotcoagulation using either monopolar or bipolar RF electrosurgicalelectrodes. The output waveform from the generator 900 can be steered,switched, or filtered to provide the frequency to the end effector ofthe surgical instrument. The connection of an ultrasonic transducer tothe generator 900 output would be preferably located between the outputlabeled ENERGY1 and RETURN as shown in FIG. 21. In one example, aconnection of RF bipolar electrodes to the generator 900 output would bepreferably located between the output labeled ENERGY2 and RETURN. In thecase of monopolar output, the preferred connections would be activeelectrode (e.g., pencil or other probe) to the ENERGY2 output and asuitable return pad connected to the RETURN output.

Additional details are disclosed in U.S. Pat. No. 10,624,691, titledTECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICALSIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS, which issued on Apr. 21,2020, which is herein incorporated by reference in its entirety.

As used throughout this description, the term “wireless” and itsderivatives may be used to describe circuits, devices, systems, methods,techniques, communications channels, etc., that may communicate datathrough the use of modulated electromagnetic radiation through anon-solid medium. The term does not imply that the associated devices donot contain any wires, although in some aspects they might not. Thecommunication module may implement any of a number of wireless or wiredcommunication standards or protocols, including but not limited to Wi-Fi(IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, long termevolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA,TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as anyother wireless and wired protocols that are designated as 3G, 4G, 5G,and beyond. The computing module may include a plurality ofcommunication modules. For instance, a first communication module may bededicated to shorter range wireless communications such as Wi-Fi andBluetooth and a second communication module may be dedicated to longerrange wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE,Ev-DO, and others.

As used herein a processor or processing unit is an electronic circuitwhich performs operations on some external data source, usually memoryor some other data stream. The term is used herein to refer to thecentral processor (central processing unit) in a system or computersystems (especially systems on a chip (SoCs)) that combine a number ofspecialized “processors.”

As used herein, a system on a chip or system on chip (SoC or SOC) is anintegrated circuit (also known as an “IC” or “chip”) that integrates allcomponents of a computer or other electronic systems. It may containdigital, analog, mixed-signal, and often radio-frequency functions—allon a single substrate. A SoC integrates a microcontroller (ormicroprocessor) with advanced peripherals like graphics processing unit(GPU), Wi-Fi module, or coprocessor. A SoC may or may not containbuilt-in memory.

As used herein, a microcontroller or controller is a system thatintegrates a microprocessor with peripheral circuits and memory. Amicrocontroller (or MCU for microcontroller unit) may be implemented asa small computer on a single integrated circuit. It may be similar to aSoC; an SoC may include a microcontroller as one of its components. Amicrocontroller may contain one or more core processing units (CPUs)along with memory and programmable input/output peripherals. Programmemory in the form of Ferroelectric RAM, NOR flash or OTP ROM is alsooften included on chip, as well as a small amount of RAM.Microcontrollers may be employed for embedded applications, in contrastto the microprocessors used in personal computers or other generalpurpose applications consisting of various discrete chips.

As used herein, the term controller or microcontroller may be astand-alone IC or chip device that interfaces with a peripheral device.This may be a link between two parts of a computer or a controller on anexternal device that manages the operation of (and connection with) thatdevice.

Any of the processors or microcontrollers described herein, may beimplemented by any single core or multicore processor such as thoseknown under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising on-chipmemory of 256 KB single-cycle flash memory, or other non-volatilememory, up to 40 MHz, a prefetch buffer to improve performance above 40MHz, a 32 KB single-cycle serial random access memory (SRAM), internalread-only memory (ROM) loaded with StellarisWare® software, 2 KBelectrically erasable programmable read-only memory (EEPROM), one ormore pulse width modulation (PWM) modules, one or more quadratureencoder inputs (QEI) analog, one or more 12-bit Analog-to-DigitalConverters (ADC) with 12 analog input channels, details of which areavailable for the product datasheet.

In one aspect, the processor may comprise a safety controller comprisingtwo controller-based families such as TMS570 and RM4x known under thetrade name Hercules ARM Cortex R4, also by Texas Instruments. The safetycontroller may be configured specifically for IEC 61508 and ISO 26262safety critical applications, among others, to provide advancedintegrated safety features while delivering scalable performance,connectivity, and memory options.

Modular devices include the modules (as described in connection withFIGS. 3 and 9, for example) that are receivable within a surgical huband the surgical devices or instruments that can be connected to thevarious modules in order to connect or pair with the correspondingsurgical hub. The modular devices include, for example, intelligentsurgical instruments, medical imaging devices, suction/irrigationdevices, smoke evacuators, energy generators, ventilators, insufflators,and displays. The modular devices described herein can be controlled bycontrol algorithms. The control algorithms can be executed on themodular device itself, on the surgical hub to which the particularmodular device is paired, or on both the modular device and the surgicalhub (e.g., via a distributed computing architecture). In someexemplifications, the modular devices' control algorithms control thedevices based on data sensed by the modular device itself (i.e., bysensors in, on, or connected to the modular device). This data can berelated to the patient being operated on (e.g., tissue properties orinsufflation pressure) or the modular device itself (e.g., the rate atwhich a knife is being advanced, motor current, or energy levels). Forexample, a control algorithm for a surgical stapling and cuttinginstrument can control the rate at which the instrument's motor drivesits knife through tissue according to resistance encountered by theknife as it advances.

Data Management and Collection

In one aspect the surgical hub provides data storage capabilities. Thedata storage includes creation and use of self-describing data includingidentification features, management of redundant data sets, and storageof the data in a manner of paired data sets which can be grouped bysurgery but not necessarily keyed to actual surgical dates and surgeonsto maintain data anonymity. The following description incorporates byreference all of the “hub” and “cloud” analytics system hardware andsoftware processing techniques to implement the specific data managementand collection techniques described hereinbelow, as incorporated byreference herein. FIGS. 22-41 will be described in the context of theinteractive surgical system 100 environment including a surgical hub106, 206 described in connection FIGS. 1-11 and intelligent instrumentsand generators described in connection with FIGS. 12-21.

Electronic Medical Record (EMR) Interaction

FIG. 22 is a diagram 4000 illustrating a technique for interacting witha patient Electronic Medical Record (EMR) database 4002, according toone aspect of the present disclosure. In one aspect, the presentdisclosure provides a method of embedding a key 4004 within the EMRdatabase 4002 located within the hospital or medical facility. A databarrier 4006 is provided to preserve patient data privacy and allows thereintegration of stripped and isolated data pairs, as describedhereinbelow, from the surgical hub 106, 206 or the cloud 104, 204, to bereassembled. A schematic diagram of the surgical hub 206 is describedgenerally in FIGS. 1-11 and in particular in FIGS. 9-10. Therefore, inthe description of FIG. 22, the reader is guided to FIG. 1-11 and inparticular FIGS. 9-10 for any implementation details of the surgical hub206 that may be omitted here for conciseness and clarity of disclosure.Returning to FIG. 22, the method allows the users full access to all thedata collected during a surgical procedure and patient informationstored in the form of electronic medical records 4012. The reassembleddata can be displayed on a monitor 4010 coupled to the surgical hub 206or secondary monitors but is not permanently stored on any surgical hubstorage device 248. The reassembled data is temporarily stored in astorage device 248 located either in the surgical hub 206 or the cloud204 and is deleted at the end of its use and overwritten to insure itcannot be recovered. The key 4004 in the EMR database 4002 is used toreintegrate anonymized hub data back into full integrated patientelectronic medical records 4012 data.

As shown in FIG. 22, the EMR database 4002 is located within thehospital data barrier 4006. The EMR database 4002 may be configured forstoring, retrieving, and managing associative arrays, or other datastructures known today as a dictionary or hash. Dictionaries contain acollection of objects, or records, which in turn have many differentfields within them, each containing data. The patient electronic medicalrecords 4012 may be stored and retrieved using a key 4004 that uniquelyidentifies the patient electronic medical record 4012, and is used toquickly find the data within the EMR database 4002. The key-value EMRdatabase 4002 system treats the data as a single opaque collection whichmay have different fields for every record.

Information from the EMR database 4002 may be transmitted to thesurgical hub 206 and the patient electronic medical records 4012 data isredacted and stripped before it is sent to an analytics system basedeither on the hub 206 or the cloud 204. An anonymous data file 4016 iscreated by redacting personal patient data and stripping relevantpatient data 4018 from the patient electronic medical record 4012. Asused herein, the redaction process includes deleting or removingpersonal patient information from the patient electronic medical record4012 to create a redacted record that includes only anonymous patientdata. A redacted record is a record from which sensitive patientinformation has been expunged. Un-redacted data may be deleted 4019. Therelevant patient data 4018 may be referred to herein asstripped/extracted data 4018. The relevant patient data 4018 is used bythe surgical hub 206 or cloud 204 processing engines for analyticpurposes and may be stored on the storage device 248 of the surgical hub206 or may be stored on the cloud 204 based analytics system storagedevice 205. The surgical hub anonymous data file 4016 can be rebuiltusing a key 4004 stored in the EMR database 4002 to reintegrate thesurgical hub anonymous data file 4016 back into a fully integratedpatient electronic medical record 4012. The relevant patient data 4018that is used in analytic processes may include information such as thepatient's diagnoses of emphysema, pre-operative treatment (e.g.,chemotherapy, radiation, blood thinner, blood pressure medication,etc.), typical blood pressures, or any data that alone cannot be used toascertain the identity of the patient. Data 4020 to be redacted includespersonal information removed from the patient electronic medical record4012, may include age, employer, body mass index (BMI), or any data thatcan be used to ascertain the identify of the patient. The surgical hub206 creates a unique anonymous procedure ID number (e.g., 380i4z), forexample, as described in FIG. 23. Within the EMR database 4002 locatedin the hospital data barrier 4006, the surgical hub 206 can reunite thedata in the anonymous data file 4016 stored on the surgical hub 206storage device 248 with the data in the patient electronic medicalrecord 4012 stored on the EMR database 4002 for surgeon review. Thesurgical hub 206 displays the combined patient electronic medical record4012 on a display or monitor 4010 coupled to the surgical hub 206.Ultimately, un-redacted data is deleted 4019 from the surgical hub 206storage 248.

Creation of a Hospital Data Barrier, Inside which the Data from Hubs canbe Compared Using Non-Anonymized Data and Outside of which the Data hasto be Stripped

In one aspect, the present disclosure provides a surgical hub 206 asdescribed in FIGS. 9 and 10, for example, where the surgical hub 206comprises a processor 244; and a memory 249 coupled to the processor244. The memory 249 stores instructions executable by the processor 244to interrogate a surgical instrument 235, retrieve a first data set fromthe surgical instrument 235, interrogate a medical imaging device 238,retrieve a second data set from the medical imaging device 238,associate the first and second data sets by a key, and transmit theassociated first and second data sets to a remote network, e.g., thecloud 204, outside of the surgical hub 206. The surgical instrument 235is a first source of patient data and the first data set is associatedwith a surgical procedure. The medical imaging device 238 is a secondsource of patient data and the second data set is associated with anoutcome of the surgical procedure. The first and second data records areuniquely identified by the key.

In another aspect, the surgical hub 206 provides a memory 249 storinginstructions executable by the processor 244 to retrieve the first dataset using the key, anonymize the first data set, retrieve the seconddata set using the key, anonymize the second data set, pair theanonymized first and second data sets, and determine success rate ofsurgical procedures grouped by the surgical procedure based on theanonymized paired first and second data sets.

In another aspect, the surgical hub 206 provides a memory 249 storinginstructions executable by the processor 244 to retrieve the anonymizedfirst data set, retrieve the anonymized second data set, and reintegratethe anonymized first and second data sets using the key.

In another aspect, the first and second data sets define first andsecond data payloads in respective first and second data packets.

In various aspects, the present disclosure provides a control circuit toassociate the first and second data sets by a key as described above. Invarious aspects, the present disclosure provides a non-transitorycomputer readable medium storing computer readable instructions which,when executed, causes a machine to associate the first and second datasets by a key as described above.

During a surgical procedure it would be desirable to monitor dataassociated with the surgical procedure to enable configuration andoperation of instruments used during the procedure to improve surgicaloutcomes. The technical challenge is to retrieve the data in a mannerthat maintains the anonymity of the patient to maintain privacy of thedata associated with the patient. The data may be used forconglomeration with other data without individualizing the data.

One solution provides a surgical hub 206 to interrogate an electronicmedical records database 4002 for patient electronic medical records4012 data, strip out desirable or relevant patient data 4018 from thepatient electronic medical record 4012, and redact any personalinformation that could be used to identify the patient. The redactiontechnique removes any information that could be used to correlate thestripped relevant patient data 4018 to a specific patient, surgery, ortime. The surgical hub 206 and the instruments 235 coupled to thesurgical hub 206 can then be configured and operated based on thestripped relevant patient data 4018.

As disclosed in connection with FIG. 22, extracting (or stripping)relevant patient data 4018 from a patient electronic medical record 4012while redacting any information that can be used to correlate thepatient with the surgery or a scheduled time of the surgery enables therelevant patient data 4018 to be anonymized. The anonymous data file4016 can then be sent to the cloud 204 for aggregation, processing, andmanipulation. The anonymous data file 4016 can be used to configure thesurgical instrument 235, or any of the modules shown in FIGS. 9 and 10or the surgical hub 206 during the surgery based on the extractedanonymous data file 4016.

In one aspect, a hospital data barrier 4006 is created such that insidethe data barrier 4006 data from various surgical hubs 206 can becompared using non-anonymized un-redacted data and outside the databarrier 4006 data from various surgical hubs 206 are stripped tomaintain anonymity and protect the privacy of the patient and thesurgeon. This aspect is discussed further in connection with FIG. 26.

In one aspect, the data from a surgical hub 206 can be exchanged betweensurgical hubs 206 (e.g., hub-to-hub, switch-to-switch, orrouter-to-router) to provide in-hospital analysis and display of thedata. FIG. 1 shows an example of multiple hubs 106 in communicationwhich each other and with the cloud 104. This aspect also is discussedfurther in connection with FIG. 26.

In another aspect, an artificial time measure is substituted for a realtime clock for all information stored internally within an instrument235, a robot located in a robot hub 222, a surgical hub 206, and/orhospital computer equipment. The anonymized data, which may includeanonymized patient and surgeon data, is transmitted to the server 213 inthe cloud 204 and it is stored in the cloud storage device 205 coupledto the server 213. The substitution of an artificial real time clockenables anonymizing the patient data and surgeon data while maintainingdata continuity. In one aspect, the instrument 235, robot hub 222,surgical hub 206, and/or the cloud 204 are configured to obscure patientidentification (ID) while maintaining data continuity. This aspect isdiscussed further in connection with FIG. 23.

Within the surgical hub 206, a local decipher key 4004 allowsinformation retrieved from the surgical hub 206 itself to reinstate thereal-time information from the anonymized data set located in theanonymous data file 4016. The data stored on the hub 206 or the cloud204, however, cannot be reinstated to real-time information from theanonymized data set in the anonymous data file 4016. The key 4004 isheld locally in the surgical hub 206 computer/storage device 248 in anencrypted format. The surgical hub 206 network processor ID is part ofthe decryption mechanism such that if the key 4004 and data is removed,the anonymized data set in the anonymous data file 4016 cannot berestored without being on the original surgical hub 206 computer/storagedevice 248.

Substituting Artificial Time Measure for Real Time Clock for allInternally Stored Information and Sent to the Cloud as a Means toAnonymizing the Patient and Surgeon Data

FIG. 23 illustrates a process 4030 of anonymizing a surgical procedureby substituting an artificial time measure for a real time clock for allinformation stored internally within the instrument, robot, surgicalhub, and/or hospital computer equipment, according to one aspect of thepresent disclosure. As shown in FIG. 23, the surgical procedure set-upstart time 4032 was scheduled to begin at an actual time of 11:31:14(EST) based on a real time clock. At the stated procedure set-up starttime 4032, the surgical hub 206 starts 4034 an artificial randomizedreal time clock timing scheme at artificial real time at 07:36:00. Thesurgical hub 206 then ultrasonically pings 4036 the operating theater(e.g., sends out a burst of ultrasound and listens for the echo when itbounces off the perimeter walls of an operating theater (e.g., a fixed,mobile, temporary, or field the operating room) as described inconnection with FIG. 24 to verify the size of the operating theater andto adjust short range wireless, e.g., Bluetooth, pairing distance limitsat artificial real time 07:36:01. At artificial real time 07:36:03, thesurgical hub 206 strips 4038 the relevant data and applies a time stampto the stripped data. At artificial real time 07:36:05, the surgical hub206 wakes up and begins pairing 4040 only devices located within theoperating theater as verified using the ultrasonic pinging 4036 process.

FIG. 24 illustrates ultrasonic pinging of an operating room wall todetermine a distance between a surgical hub and the operating room wall,in accordance with at least one aspect of the present disclosure. Withreference also to FIG. 2, the spatial awareness of the surgical hub 206and its ability to map an operating room for potential components of thesurgical system allows the surgical hub 206 to make autonomous decisionsabout whether to include or exclude such potential components as part ofthe surgical system, which relieves the surgical staff from dealing withsuch tasks. Furthermore, the surgical hub 206 is configured to makeinferences about, for example, the type of surgical procedure to beperformed in the operating room based on information gathered prior to,during, and/or after the performance of the surgical procedure. Examplesof gathered information include the types of devices that are broughtinto the operating room, time of introduction of such devices into theoperating room, and/or the devices sequence of activation.

In one aspect, the surgical hub 206 employs the operating-room mappingmodule, such as, for example, the non-contact sensor module 242 todetermine the bounds of the surgical theater (e.g., a fixed, mobile, ortemporary operating room or space) using either ultrasonic or lasernon-contact measurement devices.

Referring now to FIG. 24, ultrasound based non-contact sensors 3002 canbe employed to scan the operating theater by transmitting a burst ofultrasound and receiving the echo when it bounces off a perimeter wall3006 of an operating theater to determine the size of the operatingtheater and to adjust short range wireless, e.g., Bluetooth, pairingdistance limits. In one example, the non-contact sensors 3002 can bePing ultrasonic distance sensors, as illustrated in FIG. 24.

FIG. 24 shows how an ultrasonic sensor 3002 sends a brief chirp with itsultrasonic speaker 3003 and makes it possible for a micro-controller3004 of the operating-room mapping module to measure how long the echotakes to return to the ultrasonic sensor's ultrasonic microphone 3005.The micro-controller 3004 has to send the ultrasonic sensor 3002 a pulseto begin the measurement. The ultrasonic sensor 3002 then waits longenough for the micro-controller program to start a pulse input command.Then, at about the same time the ultrasonic sensor 3002 chirps a 40 kHztone, it sends a high signal to the micro-controller 3004. When theultrasonic sensor 3002 detects the echo with its ultrasonic microphone3005, it changes that high signal back to low. The micro-controller'spulse input command measures the time between the high and low changes,and stores it measurement in a variable. This value can be used alongwith the speed of sound in air to calculate the distance between thesurgical hub 106 and the operating-room wall 3006.

In one example, a surgical hub 206 can be equipped with four ultrasonicsensors 3002, wherein each of the four ultrasonic sensors is configuredto assess the distance between the surgical hub 206 and a wall of theoperating room 3000. A surgical hub 206 can be equipped with more orless than four ultrasonic sensors 3002 to determine the bounds of anoperating room.

Other distance sensors can be employed by the operating-room mappingmodule to determine the bounds of an operating room. In one example, theoperating-room mapping module can be equipped with one or morephotoelectric sensors that can be employed to assess the bounds of anoperating room. In one example, suitable laser distance sensors can alsobe employed to assess the bounds of an operating room. Laser basednon-contact sensors may scan the operating theater by transmitting laserlight pulses, receiving laser light pulses that bounce off the perimeterwalls of the operating theater, and comparing the phase of thetransmitted pulse to the received pulse to determine the size of theoperating theater and to adjust short range wireless, e.g., Bluetooth,pairing distance limits.

Stripping Out Data from Images and Connected Smart Instrument Data toAllow Conglomeration but not Individualization

In one aspect, the present disclosure provides a data stripping methodwhich interrogates the electronic patient records provided, extracts therelevant portions to configure and operate the surgical hub andinstruments coupled to the surgical hub, while anonymizing the surgery,patient, and all identifying parameters to maintain patient privacy.

With reference now back to FIG. 23 and also to FIGS. 1-11 to showinteraction with an interactive surgical system 100 environmentincluding a surgical hub 106, 206, once the size of the operatingtheater has been verified and Bluetooth pairing is complete, based onartificial real time, the computer processor 244 of the surgical hub 206begins stripping 4038 data received from the modules coupled to thesurgical hub 206. In one example, the processor 244 begins stripping4083 images received from the imaging module 238 and connected smartinstruments 235, for example. Stripping 4038 the data allowsconglomeration of the data but not individualization of the data. Thisenables stripping 4038 the data identifier, linking the data, andmonitoring an event while maintaining patient privacy by anonymizing thedata.

With reference to FIGS. 1-24, in one aspect, a data stripping 4038method is provided. In accordance with the data stripping 4038 method,the surgical hub 206 processor 244 interrogates the patient recordsstored in the surgical hub database 238 and extracts the relevantportions of the patient records to configure and operate the surgicalhub 206 and its instruments 235, robots, and other modular devices,e.g., modules. The data stripping 4038 method anonymizes the surgicalprocedure, patient, and all identifying parameters associated with thesurgical procedure. Stripping 4038 the data on the fly ensures that atno time the data is correlated to a specific patient, surgicalprocedure, surgeon, time or other possible identifier that can be usedto correlate the data.

The data may be stripped 4038 for compilation of the base information ata remote cloud 204 database storage device 205 coupled to the remoteserver 213. The data stored in the database storage device 248 can beused in advanced cloud based analytics, as described in U.S. ProvisionalPatent Application Ser. No. 62/611,340, filed Dec. 28, 2017, titledCLOUD-BASED MEDICAL ANALYTICS, which is incorporated herein by referencein its entirety. A copy of the information with data links intact alsocan be stored into the patient EMR database 4002 (FIG. 22). For example,the surgical hub 206 may import patient tissue irregularities orco-morbidities to add to an existing data set stored in the database248. The data may be stripped 4038 before the surgery and/or may bestripped 4038 as the data is transmitted to the cloud 204 databasestorage device 205 coupled to the remote server 213.

With continued reference to FIGS. 1-11 and 22-24, FIG. 25 is a diagram4050 depicting the process of importing patient electronic medicalrecords 4012 containing surgical procedure and relevant patient data4018 stored in the EMR database 4002, stripping 4038 the relevantpatient data 4018 from the imported medical records 4012, andidentifying 4060 smart device implications 4062, or inferences,according to one aspect of the present disclosure. As shown in FIG. 25,the patient electronic medical records 4012, containing informationstored in the patient EMR database 4002, are retrieved from the EMRdatabase 4002, imported into the surgical hub 206, and stored in thesurgical hub 206 storage device 248. Un-redacted data is removed ordeleted 4019 from the patient electronic medical records 4012 beforethey are stored in the surgical hub 206 storage device 248 as ananonymous data file 4016 (FIG. 22). The relevant patient data 4018 isthen stripped 4038 from the medical records 4012 to remove the desiredrelevant patient data 4018 and delete 4019 un-redacted data to maintainpatient anonymity. In the illustrated example, the stripped data 4058includes emphysema, high blood pressure, small lung cancer,warfarin/blood thinner, and/or radiation pretreatment. The stripped data4058 is employed to identify 4060 smart device implications whilemaintaining patient anonymity as described hereinbelow.

Although the surgical procedure data and relevant patient data 4018 isdescribed as being imported from patient electronic medical records 4012stored in the EMR database 4002, in various aspects, the surgicalprocedure data and relevant patient data 4018 may be retrieved from amodular device coupled to the surgical hub 206 before being stored inthe EMR database 4002. For example, the surgical hub 206 may interrogatethe module to retrieve the surgical procedure data and relevant patientdata 4018 from the module. As described herein, a module includes animaging module 238 that is coupled to an endoscope 239, a generatormodule 240 that is coupled to an energy device 241, a smoke evacuatormodule 226, a suction/irrigation module 228, a communication module 230,a processor module 232, a storage array 234, a smart device/instrument235 optionally coupled to a display 237, and a non-contact sensor module242, among other modules as illustrated in FIGS. 3 and 8-10.

For example, the anonymized stripped data 4058 may be employed toidentify 4060 catastrophic failures of instruments, and other smartdevices, and may initiate an automatic archive process and submission ofdata for further implications analysis. For example, the implication ofdetecting a counterfeit component or adapter on an original equipmentmanufacturer (OEM) device would be to initiate documentation of thecomponent and recording of the results and outcome of its use. Forexample, the surgical hub 206 may execute situational awarenessalgorithms as described in connection FIG. 41. In one aspect, thesurgical hub 206 may initially receive or identify a variety ofimplications 4062 that are derived from anonymized stripped data 4058.The surgical hub 206 is configured to control the instruments 235, orother modules, so that they operate correspondingly to the derivedimplications 4062. In one example, the surgical hub 206 control logicidentifies that (i) lung tissue may be more fragile than normal (e.g.,due to emphysema), (ii) hemostasis issues are more likely (e.g., due tohigh blood pressure and/or the patient being on a blood thinner, such aswarfarin), (iii) cancer may be more aggressive (e.g., due to the targetof the procedure being a small cell lung cancer), and (iv) lung tissuemay be stiffer and more prone to fracture (e.g., due to the patienthaving received a radiation pretreatment). The control logic orprocessor 244 of the surgical hub 206 then interprets how this dataimpacts the instruments 235, or other modules, so that the instruments235 are operated consistently with the data and then communicates thecorresponding adjustments to each of the instruments 235.

In one example relating to a stapler type of surgical instrument 235,based on the implications 4062 identified 4060 from the anonymizedstripped data 4058, the control logic or processor 244 of the surgicalhub 206 may (i) notify the stapler to adjust the compression ratethreshold parameter, (ii) adjust the surgical hub 206 visualizationthreshold value to quantify the bleeding and internal parameters, (iii)notify the combo generator module 240 of the lung tissue and vesseltissue types so that the power and generator module 240 controlalgorithms are adjusted accordingly, (iv) notify the imaging module 238of the aggressive cancer tag to adjust the margin ranges accordingly,(v) notify the stapler of the margin parameter adjustment needed (themargin parameter corresponds to the distance or amount of tissue aroundthe cancer that will be excised), and (vi) notify the stapler that thetissue is potentially fragile. Furthermore, the anonymized stripped data4058, upon which the implications 40602 are based, is identified by thesurgical hub 206 and is fed into the situational awareness algorithm(see FIG. 41). Examples include, without limitations, thoracic lungresection, e.g., segmentectomy, among others.

FIG. 26 is a diagram 4070 illustrating the application of cloud basedanalytics to un-redacted data, stripped relevant patient data 4018, andindependent data pairs, according to one aspect of the presentdisclosure. As shown, multiple surgical hubs Hub #1 4072, Hub #3 4074,and Hub #4 4076 are located within the hospital data barrier 4006 (seealso FIG. 22). The un-redacted patient electronic medical record 4012including patient data and surgery related data may be used andexchanged between the surgical hubs: Hub #1 4072, Hub #3 4074, and Hub#4 4076 located within the hospital data barrier 4006. Prior totransmitting the un-redacted patient electronic medical record 4012containing patient data and surgery related data outside the hospitaldata barrier 4006, however, the patient electronic medical record 4012patient data is redacted and stripped to create an anonymous data file4016 containing anonymized information for further analysis andprocessing of the redacted/stripped data by a cloud based analyticprocesses in the cloud 204.

FIG. 27 is a logic flow diagram 4080 of a process depicting a controlprogram or a logic configuration for associating patient data sets fromfirst and second sources of data, according to one aspect of the presentdisclosure. With reference to FIG. 27 and with reference also to FIGS.1-11 to show interaction with an interactive surgical system 100environment including a surgical hub 106, 206, in one aspect, thepresent disclosure provides a surgical hub 206, comprising a processor244; and a memory 249 coupled to the processor 244. The memory 249stores instructions executable by the processor 244 to interrogate 4082a surgical instrument 235, retrieve 4084 a first data set from thesurgical instrument 235, interrogate 4086 a medical imaging device 238,retrieve 4088 a second data set from the medical imaging device 238,associate 4090 the first and second data sets by a key, and transmit theassociated first and second data sets to a remote network outside of thesurgical hub 206. The surgical instrument 235 is a first source ofpatient data and the first data set is associated with a surgicalprocedure. The medical imaging device 238 is a second source of patientdata and the second data set is associated with an outcome of thesurgical procedure. The first and second data records are uniquelyidentified by the key.

In another aspect, the surgical hub 206 provides a memory 249 storinginstructions executable by the processor 244 to retrieve the first dataset using the key, anonymize the first data set, retrieve the seconddata set using the key, anonymize the second data set, pair theanonymized first and second data sets, and determine success rate ofsurgical procedures grouped by the surgical procedure based on theanonymized paired first and second data sets.

In another aspect, the surgical hub 206 provides a memory 249 storinginstructions executable by the processor 244 to retrieve the anonymizedfirst data set, retrieve the anonymized second data set, and reintegratethe anonymized first and second data sets using the key.

FIG. 28 is a logic flow diagram of a process 4400 depicting a controlprogram or a logic configuration for stripping data to extract relevantportions of the data to configure and operate the surgical hub 206 andmodules (e.g., instruments 235) coupled to the surgical hub 206,according to one aspect of the present disclosure. With reference toFIG. 28 and with reference also to FIGS. 1-11 to show interaction withan interactive surgical system 100 environment including a surgical hub106, 206, in one aspect, the surgical hub 206 may be configured tointerrogate a module coupled to surgical hub 206 for data, and strip thedata to extract relevant portions of the data to configure and operatethe surgical hub 206 and modules (e.g., instruments 235) coupled to thesurgical hub 206 and anonymize the surgery, patient, and otherparameters that can be used to identify the patient to maintain patientprivacy. According to the process 4400, in one aspect the presentdisclosure provides a surgical hub 206 including a processor 244, amodular communication hub 203 coupled to the processor 244, where themodular communication hub 203 is configured to connect modular deviceslocated in one or more operating theaters to the surgical hub 206. Theprocessor 244 is coupled to a memory 249, where the memory 249 storesinstructions executable by the processor 244 to cause the processor tointerrogate 4402 a modular device coupled to the processor 244 via themodular communication hub 203. The modular device is a source of datasets that include patient identity data and surgical procedure data. Theprocessor 244 receives 4404 a data set from the modular device. Theprocessor 244 discards 4406 the patient identity data and any portion ofthe surgical procedure data that identifies the patient from the dataset. The processor 244 extracts 4408 anonymous data from the data setand creates 4410 an anonymized data set. The processor 244 configures4412 the operation of the surgical hub 206 or the modular device basedon the anonymized data set.

In another aspect, where the anonymized data set includes catastrophicfailure of a modular device, the memory 249 stores instructionsexecutable by the processor 244 to initiate automatic archiving andsubmission of data for implications analysis based on the catastrophicfailure of the modular device. In another aspect, the memory 249 storesinstructions executable by the processor 244 to detect counterfeitcomponent information from the anonymized data set. In another aspect,the memory 249 stores instructions executable by the processor 244 toderive implications of the modular device from the anonymized data setand the memory 249 stores instructions executable by the processor 244to configure the modular device to operate based on the derivedimplications or to configure the surgical hub based on the derivedimplications. In another aspect, the memory 249 stores instructionsexecutable by the processor 244 to conglomerate the anonymized data. Inanother aspect, the memory 249 stores instructions executable by theprocessor 244 to extract the anonymized data prior to storing thereceived data in a storage device coupled to the surgical hub. Inanother aspect, the memory 249 stores instructions executable by theprocessor to transmit the anonymized data to a remote network outside ofthe surgical hub, compile the anonymized data at the remote network, andstore a copy of the data set from the modular device in a patientelectronic medical records database.

Storage of Data Creation and Use of Self-Describing Data IncludingIdentification Features

In one aspect, the present disclosure provides self-describing datapackets generated at the issuing instrument and including identifiersfor all devices that handled the packet. The self description allows theprocessor to interpret the data in the self-describing packet withoutknowing the data type in advance prior to receipt of the self-describingpacket. The data applies to every data point or data string and includesthe type of data, the source of the self-describing packet, the deviceidentification that generated the packet, the units, the time ofgeneration of the packet, and an authentication that the data containedin the packet is unaltered. When the processor (in the device or thesurgical hub) receives an unexpected packet and verifies the source ofthe packet, the processor alters the collection techniques to be readyfor any subsequent packets from that source.

With reference also to FIGS. 1-11 to show interaction with aninteractive surgical system 100 environment including a surgical hub106, 206, during a surgical procedure being performed in a surgical hub206 environment, the size and quantity of data being generated bysurgical devices 235 coupled to the surgical hub 206 can become quitelarge. Also, data exchanged between the surgical devices 235 and/or thesurgical hub 206 can become quite large.

One solution provides a techniques for minimizing the size of the dataand handling the data within a surgical hub 206 by generating aself-describing packet. The self-describing packet is initiallyassembled by the instrument 235 that generated it. The packet is thenordered and encrypted b generating an encryption certificate which isunique for each data packet. The data is then communicated from theinstrument 235 via encrypted wired or wireless protocols and stored onthe surgical hub 206 for processing and transmission to the cloud 204analytics engine. Each self-describing data packet includes anidentifier to identify the specific instrument that generated it and thetime it was generated. A surgical hub 206 identifier is added to thepacket when the packet is received by the surgical hub 206.

In one aspect, the present disclosure provides a surgical hub 206comprising a processor 244 and a memory 249 coupled to the processor244. The memory 249 storing instructions executable by the processor 244to receive a first data packet from a first source, receive a seconddata packet from a second source, associate the first and second datapackets, and generate a third data packet comprising the first andsecond data payloads. The first data packet comprises a first preamble,a first data payload, a source of the first data payload, and a firstencryption certificate. The first preamble defines the first datapayload and the first encryption certificate verifies the authenticityof the first data packet. The second data packet comprises a secondpreamble, a second data payload, a source of the second data payload,and a second encryption certificate. The second preamble defines thesecond data payload and the second encryption certificate verifies theauthenticity of the second data packet.

In another aspect, the memory 249 stores instructions executable by theprocessor 244 to determine that a data payload is from a new source,verify the new source of the data payload, and alter a data collectionprocess at the surgical hub to receive subsequent data packets from thenew source.

In another aspect, the memory 249 stores instructions executable by theprocessor 244 to associate the first and second data packets based on akey. In another aspect, the memory 249 stores instructions executable bythe processor 244 to anonymize the data payload of the third datapacket. In another aspect, the memory 249 stores instructions executableby the processor 244 to receive an anonymized third data packet andreintegrate the anonymized third data packet into the first and seconddata packets using the key.

In various aspects, the present disclosure provides a control circuit toreceive and process data packets as described above. In various aspects,the present disclosure provides a non-transitory computer-readablemedium storing computer readable instructions, which when executed,causes a machine to receive and process data packets as described above.

In other aspects, the present disclosure a method of generating a datapacket comprising self-describing data. In one aspect, a surgicalinstrument includes a processor and a memory coupled to the processor, acontrol circuit, and/or a computer-readable medium configured togenerate a data packet comprising a preamble, a data payload, a sourceof the data payload, and an encryption certificate. The preamble definesthe data payload and the encryption certificate verifies theauthenticity of the data packet. In various aspects, the data packet maybe generated by any module coupled to the surgical hub. Self-describingdata packets minimize data size and data handing in the surgical hub.

In one aspect, the present disclosure provides a self-describing datapacket generated at an issuing device (e.g., instrument, tool, robot).The self-describing data packet comprises identifiers for all devicesthat handle the data packet along a communication path; a selfdescription to enable a processor to interpret that data contained inthe data packet without having been told in advance of receipt of thedata packet along a path; data for every data point or data string; andtype of data, source of data, device IDs that generated the data, unitsof the data, time of generation, and authentication that the data packetis unaltered. In another aspect, when a processor receives a data packetfrom an unexpected source and verifies the source of the data, theprocessor alters the data collection technique to prepare for anysubsequent data packets from the source.

In the creation and use of a data packet comprising self-describingdata, the surgical hub includes identification features. The hub andintelligent devices use self-describing data packets to minimize datasize and data handling. In a surgical hub that generates large volumesof data, the self-describing data packets minimize data size and datahandling, thus saving time and enabling the operating theater to runmore efficiently.

FIG. 29 illustrates a self-describing data packet 4100 comprisingself-describing data, according to one aspect of the present disclosure.With reference also to FIGS. 1-11 to show interaction with aninteractive surgical system 100 environment including a surgical hub106, 206, in one aspect, self-describing data packets 4100 as shown inFIG. 29 are generated at an issuing instrument 235, or device or modulelocated in or in communication with the operating theater, and includeidentifiers for all devices 235 that handle the packet along acommunication path. The self description allows a processor 244 tointerpret the data payload of the packet 4100 without having advanceknowledge of the definition of the data payload prior to receiving theself-describing data packet 4100. The processor 244 can interpret thedata payload by parsing an incoming self-describing packet 4100 as it isreceived and identifying the data payload without being notified inadvance that the self-describing packet 4100 was received. The data isfor every data point or data string. The data payload includes type ofdata, source of data, device IDs that generated the data, data units,time when data was generated, and an authentication that theself-describing data packet 4100 is unaltered. Once the processor 244,which may be located either in the device or the surgical hub 206,receives an unexpected self-describing data packet 4100 and verifies thesource of the self-describing data packet 4100, the processor 244 altersthe data collection means to be ready for any subsequent self-describingdata packets 4100 from that source. In one example, the informationcontained in a self-describing packet 4100 may be recorded during thefirst firing 4172 in the lung tumor resection surgical proceduredescribed in connection with FIGS. 31-35.

The self-describing data packet 4100 includes not only the data but apreamble which defines what the data is and where the data came from aswell as an encryption certificate verifying the authenticity of eachdata packet 4100. As shown in FIG. 29, the data packet 4100 may comprisea self-describing data header 4102 (e.g., force-to-fire [FTF],force-to-close [FTC], energy amplitude, energy frequency, energy pulsewidth, speed of firing, and the like), a device ID 4104 (e.g., 002), ashaft ID 4106 (e.g., W30), a cartridge ID 4108 (e.g., ESN736), a uniquetime stamp 4110 (e.g., 09:35:15), a force-to-fire value 4112 (e.g., 85)when the self-describing data header 4102 includes FTF (force-to-fire),otherwise, this position in the data packet 4100 includes the value offorce-to-close, energy amplitude, energy frequency, energy pulse width,speed of firing, and the like. The data packet 4100, further includestissue thickness value 4114 (e.g., 1.1 mm), and an identificationcertificate of data value 4116 (e.g., 01101010001001) that is unique foreach data packet 4100. Once the self-describing data packet 4100 isreceived by another instrument 235, surgical hub 206, cloud 204, etc.,the receiver parses the self-describing data header 4102 and based onits value knows what data type is contained in the self-describing datapacket 4100. TABLE 1 below lists the value of the self-describing dataheader 4102 and the corresponding data value.

TABLE 1 Self-Describing Data Header (4102) Data Type FTF Force To Fire(N) FTC Force To Close (N) EA Energy Amplitude (J) EF Energy Frequency(Hz) EPW Energy Pulse Width (Sec) SOF Speed Of Firing (mm/sec)

Each self-describing data packet 4100 comprising self-describing data isinitially assembled by the instrument 235, device, or module thatgenerated the self-describing data packet 4100. Subsequently, theself-describing data packet 4100 comprising self-describing data isordered and encrypted to generate an encryption certificate. Theencryption certificate is unique for each self-describing data packet4100. That data is then communicated via encrypted wired or wirelessprotocols and stored on the surgical hub 206 for processing andtransmission to the cloud 204 analytics engine.

Each self-describing data packet 4100 comprising self-describing dataincludes a device ID 4104 to identify the specific instrument 235 thatgenerated the self-describing data packet 4100, a time stamp 4110 toindicate the time that the data packet 4100 was generated, and when theself-describing data packet 4100 is received by the surgical hub 206.The surgical hub 206 ID also may be added to the self-describing datapacket 4100.

Each of the self-describing data packets 4100 comprising self-describingdata may include a packet wrapper that defines the beginning of the datapacket 4100 and the end of the data packet 4100 including anyidentifiers necessary to forecast the number and order of the bits inthe self-describing data packet.

The surgical hub 206 also manages redundant data sets. As the device 235functions and interconnects with other surgical hubs 206, multiple setsof the same data may be created and stored on various devices 235.Accordingly, the surgical hub 206 manages multiple images of redundantdata as well as anonymization and security of data. The surgical hub 206also provides temporary visualization and communication, incidentmanagement, peer-to-peer processing or distributed processing, andstorage backup and protection of data.

FIG. 30 is a logic flow diagram 4120 of a process depicting a controlprogram or a logic configuration for using data packets comprisingself-describing data, according to one aspect of the present disclosure.With reference to FIGS. 1-29, in one aspect, the present disclosureprovides a surgical hub 206 comprising a processor 244 and a memory 249coupled to the processor 244. The memory 249 storing instructionsexecutable by the processor 244 to receive a first data packet from afirst source, receive a second data packet from a second source,associate the first and second data packets, and generate a third datapacket comprising the first and second data payloads. The first datapacket comprises a first preamble, a first data payload, a source of thefirst data payload, and a first encryption certificate. The firstpreamble defines the first data payload and the first encryptioncertificate verifies the authenticity of the first data packet. Thesecond data packet comprises a second preamble, a second data payload, asource of the second data payload, and a second encryption certificate.The second preamble defines the second data payload and the secondencryption certificate verifies the authenticity of the second datapacket.

In another aspect, the memory 249 stores instructions executable by theprocessor 244 to determine that a data payload is from a new source,verify the new source of the data payload, and alter a data collectionprocess at the surgical hub to receive subsequent data packets from thenew source.

In another aspect, the memory 249 stores instructions executable by theprocessor 244 to associate the first and second data packets based on akey. In another aspect, the memory 249 stores instructions executable bythe processor 244 to anonymize the data payload of the third datapacket. In another aspect, the memory 244 stores instructions executableby the processor 244 to receive an anonymized third data packet andreintegrate the anonymized third data packet into the first and seconddata packets using the key.

FIG. 31 is a logic flow diagram 4130 of a process depicting a controlprogram or a logic configuration for using data packets comprisingself-describing data, according to one aspect of the present disclosure.With reference to FIG. 31 and with reference also to FIGS. 1-11 to showinteraction with an interactive surgical system 100 environmentincluding a surgical hub 106, 206, in one aspect, the present disclosureprovides a surgical hub 206 comprising a processor 244 and a memory 249coupled to the processor 244. The memory 249 storing instructionsexecutable by the processor 244 to receive 4132 a first self-describingdata packet from a first data source, the first self-describing datapacket comprising a first preamble, a first data payload, a source ofthe first data payload, and a first encryption certificate. The firstpreamble defines the first data payload and the first encryptioncertificate verifies the authenticity of the first data packet. Thememory 249 storing instructions executable by the processor 244 to parse4134 the received first preamble and interpret 4136 the first datapayload based on the first preamble.

In various aspects, the memory 249 stores instructions executable by theprocessor 244 to receive a second self-describing data packet from asecond data source, the second self-describing data packet comprising asecond preamble, a second data payload, a source of the second datapayload, and a second encryption certificate. The second preambledefines the second data payload and the second encryption certificateverifies the authenticity of the second data packet. The memory 249storing instructions executable by the processor 244 to parse thereceived second preamble, interpret the second data payload based on thesecond preamble, associate the first and second self-describing datapackets, and generate a third self-describing data packet comprising thefirst and second data payloads. In one aspect, the memory storesinstructions executable by the processor to anonymize the data payloadof the third self-describing data packet.

In various aspects, the memory stores instructions executable by theprocessor to determine that a data payload was generated by a new datasource, verify the new data source of the data payload, and alter a datacollection process at the surgical hub to receive subsequent datapackets from the new data source. In one aspect, the memory storesinstructions executable by the processor to associate the first andsecond self-describing data packets based on a key. In another aspect,the memory stores instructions executable by the processor to receive ananonymized third self-describing data packet and reintegrate theanonymized third self-describing data packet into the first and secondself-describing data packets using the key.

Storage of the Data in a Manner of Paired Data Sets which can be Groupedby Surgery but not Necessarily Keyed to Actual Surgical Dates andSurgeons

In one aspect, the present disclosure provides a data pairing methodthat allows a surgical hub to interconnect a device measured parameterwith a surgical outcome. The data pair includes all the relevantsurgical data or patient qualifiers without any patient identifier data.The data pair is generated at two separate and distinct times. Thedisclosure further provides configuring and storing the data in such amanner as to be able to rebuild a chronological series of events ormerely a series of coupled but unconstrained data sets. The disclosurefurther provides storing data in an encrypted form and having predefinedbackup and mirroring to the cloud.

To determine the success or failure of a surgical procedure, data storedin a surgical instrument should be correlated with the outcome of thesurgical procedure while simultaneously anonymizing the data to protectthe privacy of the patient. One solution is to pair data associated witha surgical procedure, as recorded by the surgical instrument during thesurgical procedure, with data assessing the efficacy of the procedure.The data is paired without identifiers associated with surgery, patient,or time to preserve anonymity. The paired data is generated at twoseparate and distinct times.

In one aspect, the present disclosure provides a surgical hub configuredto communicate with a surgical instrument. The surgical hub comprises aprocessor and a memory coupled to the processor. The memory storinginstructions executable by the processor to receive a first data setassociated with a surgical procedure, receive a second data setassociated with the efficacy of the surgical procedure, anonymize thefirst and second data sets by removing information that identifies apatient, a surgery, or a scheduled time of the surgery, and store thefirst and second anonymized data sets to generate a data pair grouped bysurgery. The first data set is generated at a first time, the seconddata set is generated at a second time, and the second time is separateand distinct from the first time.

In another aspect, the memory stores instructions executable by theprocessor to reconstruct a series of chronological events based on thedata pair. In another aspect, the memory stores instructions executableby the processor to reconstruct a series of coupled but unconstraineddata sets based on the data pair. In another aspect, the memory storesinstructions executable by the processor to encrypt the data pair,define a backup format for the data pair, and mirror the data pair to acloud storage device.

In various aspects, the present disclosure provides a control circuit toreceive and process data sets as described above. In various aspects,the present disclosure provides a non-transitory computer-readablemedium storing computer readable instructions, which when executed,causes a machine to receive and process data sets as described above.

Storage of paired anonymous data enables the hospital or surgeon to usethe data pairs locally to link to specific surgeries or to store thedata pairs to analyze overall trends without extracting specific eventsin chronological manner.

In one aspect, the surgical hub provides user defined storage andconfiguration of data. Storage of the data may be made in a manner ofpaired data sets which can be grouped by surgery, but not necessarilykeyed to actual surgical dates and surgeons. This technique providesdata anonymity with regard to the patient and surgeon.

In one aspect, the present disclosure provides a data pairing method.The data pairing method comprises enabling a surgical hub tointerconnect a device measured parameter with an outcome, wherein a datapair includes all the relevant tissue or patient qualifiers without anyof the identifiers, wherein the data pair is generated at two distinctand separate times. In another aspect, the present disclosure provides adata configuration that includes whether the data is stored in such amanner as to enable rebuilding a chronological series of events ormerely a series of coupled but unconstrained data sets. In anotheraspect, the data may be stored in an encrypted form. The stored data maycomprise a predefined backup and mirroring to the cloud.

The data may be encrypted locally to the device. The data backup may beautomatic to an integrated load secondary storage device. The deviceand/or the surgical hub may be configured to maintain the time ofstorage of the data and compile and transmit the data to anotherlocation for storage, e.g., another surgical hub or a cloud storagedevice. The data may be grouped together and keyed for transmission tothe cloud analytics location. A cloud based analytics system isdescribed in commonly owned U.S. Provisional Patent Application Ser. No.62/611,340, filed Dec. 28, 2017, titled CLOUD-BASED MEDICAL ANALYTICS,which is incorporated herein by reference in its entirety.

In another aspect, the hub provides user selectable options for storingthe data. In one technique, the hub enables the hospital or the surgeonto select if the data should be stored in such a manner that it could beused locally in a surgical hub to link to specific surgeries. In anothertechnique, the surgical hub enables the data to be stored as data pairsso that overall trends can be analyzed without specific events extractedin a chronological manner.

FIG. 32 is a diagram 4150 of a tumor 4152 embedded in the right superiorposterior lobe 4154 of the right lung 4156, according to one aspect ofthe present disclosure. To remove the tumor 4152, the surgeon cutsaround the tumor 4152 along the perimeter generally designated as amargin 4158. A fissure 4160 separates the upper lobe 4162 and the middlelobe 4164 of the right lung 4156. In order to cut out the tumor 4152about the margin 4158, the surgeon must cut the bronchial vessels 4166leading to and from the middle lobe 4164 and the upper lobe 4162 of theright lung 4156. The bronchial vessels 4166 must be sealed and cut usinga device such as a surgical stapler, electrosurgical instrument,ultrasonic instrument, a combo electrosurgical/ultrasonic instrument,and/or a combo stapler/electrosurgical device generally representedherein as the instrument/device 235 coupled to the surgical hub 206. Thedevice 235 is configured to record data as described above, which isformed as a data packet, encrypted, stored, and/or transmitted to aremote data storage device 105 and processed by the server 113 in thecloud 104. FIGS. 37 and 38 are diagrams that illustrate the right lung4156 and the bronchial tree 4250 embedded within the parenchyma tissueof the lung.

In one aspect, the data packet may be in the form of the self-describingdata 4100 described in connection with FIGS. 29-31. The self-describingdata packet 4100 will contain the information recorded by the device 235during the procedure. Such information may include, for example, aself-describing data header 4102 (e.g., force-to-fire [FTF],force-to-close [FTC], energy amplitude, energy frequency, energy pulsewidth, speed of firing, and the like) based on the particular variable.The device ID 4104 (e.g., 002) of the instrument/device 235 used in theprocedure including components of the instrument/device 235 such as theshaft ID 4106 (e.g., W30) and the cartridge ID 4108 (e.g., ESN736). Theself-describing packet 4100 also records a unique time stamp 4110 (e.g.,09:35:15) and procedural variables such as a force-to-fire value 4112(e.g., 85) when the self-describing data header 4102 includes FTF(force-to-fire), otherwise, this position in the data packet 4100includes the value of force-to-close (FTC), energy amplitude, energyfrequency, energy pulse width, speed of firing, and the like, as shownin TABLE 1, for example. The data packet 4100, further may includetissue thickness value 4114 (e.g., 1.1 mm), which in this example refersto the thickness of the bronchial vessel 4166 exposed in the fissure4160 that were sealed and cut. Finally, each self-describing packet 4100includes an identification certificate of data value 4116 (e.g.,01101010001001) that uniquely identifies each data packet 4100transmitted by the device/instrument 235 to the surgical hub 206,further transmitted from the surgical hub 206 to the cloud 204 andstored on the storage device 205 coupled to the server 213, and/orfurther transmitted to the robot hub 222 and stored.

The data transmitted by way of a self-describing data packet 4100 issampled by the instrument device 235 at a predetermined sample rate.Each sample is formed into a self-describing data packet 4100 which istransmitted to the surgical hub 206 and eventually is transmitted fromthe surgical hub 206 to the cloud 204. The samples may be stored locallyin the instrument device 235 prior to packetizing or may be transmittedon the fly. The predetermined sampling rate and transmission rate aredictated by communication traffic in the surgical hub 206 and may beadjusted dynamically to accommodate current bandwidth limitations.Accordingly, in one aspect, the instrument device 235 may record all thesamples taken during surgery and at the end of the procedure packetizeeach sample into a self-describing packet 4100 and transmit theself-describing packet 4100 to the surgical hub 206. In another aspect,the sampled data may be packetized as it is recorded and transmitted tothe surgical hub 206 on the fly.

FIG. 33 is a diagram 4170 of a lung tumor resection surgical procedureincluding four separate firings of a surgical stapler device 235 to sealand cut bronchial vessels 4166 exposed in the fissure 4160 leading toand from the upper and lower lobes 4162, 4164 of the right lung 4156shown in FIG. 32, according to one aspect of the present disclosure. Thesurgical stapler device 235 is identified by a Device ID “002”. The datafrom each firing of the surgical stapler device 235 is recorded andformed into a data packet 4100 comprising self-describing data as shownin FIG. 30. The self-describing data packet 4100 shown in FIG. 30 isrepresentative of the first firing of device “002” having a staplecartridge serial number of ESN736, for example. In the followingdescription, reference also is made to FIGS. 12-19 for descriptions ofvarious architectures of instruments/devices 235 that include aprocessor or a control circuit coupled to a memory for recording (e.g.,saving or storing) data collected during a surgical procedure.

The first firing 4172 is recorded at anonymous time 09:35:15. The firstfiring 4172 seals and severs a first bronchial vessel 4166 leading toand from the middle lobe 4164 and the upper lobe 4162 of the right lung4156 into a first portion 4166 a and a second portion 4166 b, where eachportion 4166 a, 4166 b is sealed by respective first and second staplelines 4180 a, 4180 b. Information associated with the first firing 4172,for example the information described in connection with FIG. 30, isrecorded in the surgical stapler device 235 memory and is used to builda first self-describing data packet 4100 described in connection withFIGS. 29-31. The first self-describing packet 4100 may be transmittedupon completion of the first firing 4172 or may be kept stored in thesurgical stapler device 235 memory until the surgical procedure iscompleted. Once transmitted by the surgical stapler device 235, thefirst self-describing data packet 4100 is received by the surgical hub206. The first self-describing data packet 4100 is anonymized bystripping and time stamping 4038 the data, as discussed, for example, inconnection with FIG. 23. After the lung resection surgical is completed,the integrity of the seals of the first and second staple lines 4182 a,4182 b will be evaluated as shown in FIG. 34, for example, and theresults of the evaluation will be paired with information associatedwith the first firing 4172.

The second firing 4174 seals and severs a second bronchial vessel of thebronchial vessels 4166 leading to and from the middle lobe 4164 and theupper lobe 4162 of the right lung 4156 into a first portion 4166 c and asecond portion 4166 d, where each portion 4166 c, 4166 d is sealed byfirst and second staple lines 4180 c, 4180 d. Information associatedwith the second firing 4174, for example the information described inconnection with FIGS. 29-31, is recorded in the surgical stapler device235 memory and is used to build a second self-describing data packet4100 described in connection with FIGS. 29-31. The secondself-describing data packet 4100 may be transmitted upon completion ofthe second firing 4174 or may be kept stored in the surgical staplerdevice 235 memory until the surgical procedure is completed. Oncetransmitted by the surgical stapler device 235, the secondself-describing data packet 4100 is received by the surgical hub 206.The second self-describing data packet 4100 is anonymized by strippingand time stamping 4038 the data as discussed, for example, in connectionwith FIG. 23. After the lung resection surgical is completed, theintegrity of the seals of the first and second staple lines 4182 c, 4182d will be evaluated as shown in FIG. 34, for example, and the results ofthe evaluation will be paired with information associated with thesecond firing 4174.

The third firing 4176 is recorded at anonymous time 09:42:12. The thirdfiring 4176 seals and severs an outer portion of the upper and middlelobes 4162, 4164 of the right lung 4156. First and second staple lines4182 a, 4182 b are used to seal the outer portion of the upper andmiddle lobes 4162, 4162. Information associated with the third firing4176, for example the information described in connection with FIGS.29-31, is recorded in the surgical stapler device 235 memory and is usedto build a third self-describing data packet 4100 described inconnection with FIGS. 29-31. The third self-describing packet 4100 maybe transmitted upon completion of the third firing 4176 or may be keptstored in the surgical stapler device 235 memory until the surgicalprocedure is completed. Once transmitted by the surgical stapler device235, the third self-describing data packet 4100 is received by thesurgical hub 206. The third self-describing data packet 4100 isanonymized by stripping and time stamping 4038 the data, as discussed,for example, in connection with FIG. 23. After the lung resectionsurgical is completed, the integrity of the seals of the first andsecond staple lines 4180 a, 4180 b will be evaluated as shown in FIG.34, for example, and the results of the evaluation will be paired withinformation associated with the third firing 4172.

The fourth firing 4178 seals and severs an inner portion of the upperand middle lobes 4162, 4162 of the right lung 4156. First and secondstaple lines 4182 c, 4182 d are used to seal the inner portions of theupper and middle lobes 4162, 4164. Information associated with thefourth firing 4178, for example the information described in connectionwith FIG. 30, is recorded in the surgical stapler device 235 memory andis used to build a fourth self-describing data packet 4100 described inconnection with FIGS. 29-31. The fourth self-describing packet 4100 maybe transmitted upon completion of the fourth firing 4178 or may be keptstored in the surgical stapler device 235 memory until the surgicalprocedure is completed. Once transmitted by the surgical stapler device235, the fourth self-describing data packet 4100 is received by thesurgical hub 206. The fourth self-describing data packet 4100 isanonymized by stripping and time stamping 4038 the data, as discussed,for example, in connection with FIG. 23. After the lung resectionsurgical is completed, the integrity of the seals of the first andsecond staple lines 4182 a, 4182 b will be evaluated as shown in FIG.34, for example, and the results of the evaluation will be paired withinformation associated with the fourth firing 4172.

FIG. 34 is a graphical illustration 4190 of a force-to-close (FTC)versus time curve 4192 and a force-to-fire (FTF) versus time curve 4194characterizing the first firing 4172 of device 002 shown in FIG. 33,according to one aspect of the present disclosure. The surgical staplerdevice 235 is identified as 002 with a 30 mm staple cartridge S/N ESN736with a PVS shaft S/N M3615N (Shaft ID W30). The surgical stapler device235 was used for the first firing 4172 to complete the lung resectionsurgical procedure shown in FIG. 33. As shown in FIG. 34, the peakforce-to-fire force of 85 N. is recorded at anonymous time 09:35:15.Algorithms in the surgical stapler device 235 determine a tissuethickness of about 1.1 mm. As described hereinbelow, the FTC versus timecurve 4192 and the FTF versus time curve 4194 characterizing the firstfiring 4172 of the surgical device 235 identified by ID 002 will bepaired with the outcome of the lung resection surgical procedure,transmitted to the surgical hub 206, anonymized, and either stored inthe surgical hub 206 or transmitted to the cloud 204 for aggregation,further processing, analysis, etc.

FIG. 35 is a diagram 4200 illustrating a staple line visualization laserDoppler to evaluate the integrity of staple line seals by monitoringbleeding of a vessel after a firing of a surgical stapler, according toone aspect of the present disclosure. A laser Doppler technique isdescribed in above under the heading “Advanced Imaging AcquisitionModule,” in U.S. Provisional Patent Application Ser. No. 62/611,341,filed Dec. 28, 2017, and titled INTERACTIVE SURGICAL PLATFORM, which ishereby incorporated by reference herein in its entirety. The laserDoppler provides an image 4202 suitable for inspecting seals along thestaple lines 4180 a, 4180 b, 4182 a and for visualizing bleeding 4206 ofany defective seals. Laser Doppler inspection of the first firing 4172of device 002 shows a defective seal at the first staple line 4180 a ofthe first portion 4166 a of the bronchial vessel sealed during the firstfiring 4172. The staple line 4180 a seal is bleeding 4206 out at avolume of 0.5 cc. The image 4202 is recorded at anonymous time 09:55:154204 and is paired with the force-to-close curve 4192 and force-to-firecurve 4194 shown in FIG. 34. The data pair set is grouped by surgery andis stored locally in the surgical hub 206 storage 248 and/or remotely tothe cloud 204 storage 205 for aggregation, processing, and analysis, forexample. For example, the cloud 204 analytics engine associates theinformation contained in the first self-describing packet 4100associated with the first firing 4172 and indicate that a defective sealwas produced at the staple line 4166 a. Over time, this information canbe aggregated, analyzed, and used to improve outcomes of the surgicalprocedure, such as, resection of a lung tumor, for example.

FIG. 36 illustrates two paired data sets 4210 grouped by surgery,according to one aspect of the present disclosure. The upper paired dataset 4212 is grouped by one surgery and a lower paired data set 4214grouped by another surgery. The upper paired data set 4212, for example,is grouped by the lung tumor resection surgery discussed in connectionwith FIGS. 33-36. Accordingly, the rest of the description of FIG. 36will reference information described in FIGS. 32-35 as well as FIGS.1-21 to show interaction with an interactive surgical system 100environment including a surgical hub 106, 206. The lower paired data set4214 is grouped by a liver tumor resection surgical procedure where thesurgeon treated parenchyma tissue. The upper paired data set isassociated with a failed staple line seal and the bottom paired data setis associated with a successful staple line seal. The upper and lowerpaired data sets 4212, 4214 are sampled by the instrument device 235 andeach sample formed into a self-describing data packet 4100 which istransmitted to the surgical hub 206 and eventually is transmitted fromthe surgical hub 206 to the cloud 204. The samples may be stored locallyin the instrument device 235 prior to packetizing or may be transmittedon the fly. Sampling rate and transmission rate are dictated bycommunication traffic in the surgical hub 206 and may be adjusteddynamically to accommodate current bandwidth limitations.

The upper paired data set 4212 includes a left data set 4216 recorded bythe instrument/device 235 during the first firing 4172 linked 4224 to aright data set 4218 recorded at the time the staple line seal 4180 a ofthe first bronchial vessel 4166 a was evaluated. The left data set 4216indicates a “Vessel” tissue type 4236 having a thickness 4238 of 1.1 mm.Also included in the left data set 4216 is the force-to-close curve 4192and force-to-fire curve 4194 versus time (anonymous real time) recordedduring the first firing 4172 of the lung tumor resection surgicalprocedure. The left data set 4216 shows that the force-to-fire peaked at85 Lbs. and recorded at anonymous real time 4240 t_(1a) (09:35:15). Theright data set 4218 depicts the staple line visualization curve 4228depicting leakage versus time. The right data set 4218 indicates that a“Vessel” tissue type 4244 having a thickness 4246 of 1.1 mm experienceda staple line 4180 a seal failure 4242. The staple line visualizationcurve 4228 depicts leakage volume (cc) versus time of the staple line4180 a seal. The staple line visualization curve 4228 shows that theleakage volume reached 0.5 cc, indicating a failed staple line 4180 aseal of the bronchial vessel 4166 a, recorded at anonymous time 4248(09:55:15).

The lower paired data set 4214 includes a left data set 4220 recorded bythe instrument/device 235 during a firing linked 4226 to a right dataset 4222 recorded at the time the staple line seal of the parenchymatissue was evaluated. The left data set 4220 indicates a “Parenchyma”tissue type 4236 having a thickness 4238 of 2.1 mm. Also included in theleft data set 4220 is the force-to-close curve 4230 and force-to-firecurve 4232 versus time (anonymous real time) recorded during the firstfiring of the liver tumor resection surgical procedure. The left dataset 4220 shows that the force-to-fire peaked at 100 Lbs. and recorded atanonymous real time 4240 t_(1b) (09:42:12). The right data set 4222depicts the staple line visualization curve 4228 depicting leakageversus time. The right data set 4234 indicates that a “Parenchyma”tissue type 4244 having a thickness 4246 of 2.2 mm experienced asuccessful staple line seal. The staple line visualization curve 4234depicts leakage volume (cc) versus time of the staple line seal. Thestaple line visualization curve 4234 shows that the leakage volume was0.0 cc, indicating a successful staple line seal of the parenchymatissue, recorded at anonymous time 4248 (10:02:12).

The paired date sets 4212, 4214 grouped by surgery are collected formany procedures and the data contained in the paired date sets 4212,4214 is recorded and stored in the cloud 204 storage 205 anonymously toprotect patient privacy, as described in connection with FIGS. 22-29. Inone aspect, the paired date sets 4212, 4214 data are transmitted fromthe instrument/device 235, or other modules coupled to the surgical hub206, to the surgical hub 206 and to the cloud 204 in the form of theself-describing packet 4100 as described in connection with FIGS. 31 and32 and surgical procedure examples described in connection with FIGS.32-36. The paired date sets 4212, 4214 data stored in the cloud 204storage 205 is analyzed in the cloud 204 to provide feedback to theinstrument/device 235, or other modules coupled to the surgical hub 206,notifying a surgical robot coupled to the robot hub 222, or the surgeon,that the conditions identified by the left data set ultimately lead toeither a successful or failed seal. As described in connection with FIG.36, the upper left data set 4216 led to a failed seal and the bottomleft data set 4220 led to a successful seal. This is advantageousbecause the information provided in a paired data set grouped by surgerycan be used to improve resection, transection, and creation ofanastomosis in a variety of tissue types. The information can be used toavoid pitfalls that may lead to a failed seal.

FIG. 37 is a diagram of the right lung 4156 and FIG. 38 is a diagram ofthe bronchial tree 4250 including the trachea 4252 and the bronchi 4254,4256 of the lungs. As shown in FIG. 37, the right lung 4156 is composedof three lobes divided into the upper lobe 4162, the middle lobe 4160,and the lower lobe 4165 separated by the oblique fissure 4167 andhorizontal fissure 4160. The left lung is composed of only two smallerlobes due to the position of heart. As shown in FIG. 38, inside eachlung, the right bronchus 4254 and the left bronchus 4256 divide intomany smaller airways called bronchioles 4258, greatly increasing surfacearea. Each bronchiole 4258 terminates with a cluster of air sacs calledalveoli 4260, where gas exchange with the bloodstream occurs.

FIG. 39 is a logic flow diagram 4300 of a process depicting a controlprogram or a logic configuration for storing paired anonymous data setsgrouped by surgery, according to one aspect of the present disclosure.With reference to FIGS. 1-39, in one aspect, the present disclosureprovides a surgical hub 206 configured to communicate with a surgicalinstrument 235. The surgical hub 206 comprises a processor 244 and amemory 249 coupled to the processor 244. The memory 249 storinginstructions executable by the processor 244 to receive 4302 a firstdata set from a first source, the first data set associated with asurgical procedure, receive 4304 a second data set from a second source,the second data set associated with the efficacy of the surgicalprocedure, anonymize 4306 the first and second data sets by removinginformation that identifies a patient, a surgery, or a scheduled time ofthe surgery, and store 4308 the first and second anonymized data sets togenerate a data pair grouped by surgery. The first data set is generatedat a first time, the second data set is generated at a second time, andthe second time is separate and distinct from the first time.

In another aspect, the memory 249 stores instructions executable by theprocessor 244 to reconstruct a series of chronological events based onthe data pair. In another aspect, the memory 249 stores instructionsexecutable by the processor 244 to reconstruct a series of coupled butunconstrained data sets based on the data pair. In another aspect, thememory 249 stores instructions executable by the processor 244 toencrypt the data pair, define a backup format for the data pair, andmirror the data pair to a cloud 204 storage device 205.

Determination of Data to Transmit to Cloud Based Medical Analytics

In one aspect, the present disclosure provides a communication hub andstorage device for storing parameters and status of a surgical devicewhat has the ability to determine when, how often, transmission rate,and type of data to be shared with a cloud based analytics system. Thedisclosure further provides techniques to determine where the analyticssystem communicates new operational parameters for the hub and surgicaldevices.

In a surgical hub environment, large amounts of data can be generatedrather quickly and may cause storage and communication bottlenecks inthe surgical hub network. One solution may include local determinationof when and what data is transmitted for to the cloud-based medicalanalytics system for further processing and manipulation of surgical hubdata. The timing and rate at which the surgical hub data is exported canbe determined based on available local data storage capacity. Userdefined inclusion or exclusion of specific users, patients, orprocedures enable data sets to be included for analysis or automaticallydeleted. The time of uploads or communications to the cloud-basedmedical analytics system may be determined based on detected surgicalhub network down time or available capacity.

With reference to FIGS. 1-39, in one aspect, the present disclosureprovides a surgical hub 206 comprising a storage device 248, a processor244 coupled to the storage device 248, and a memory 249 coupled to theprocessor 244. The memory 249 stores instructions executable by theprocessor 244 to receive data from a surgical instrument 235, determinea rate at which to transfer the data to a remote cloud-based medicalanalytics network 204 based on available storage capacity of the storagedevice 248, determine a frequency at which to transfer the data to theremote cloud-based medical analytics network 204 based on the availablestorage capacity of the storage device 248 or detected surgical hubnetwork 206 down time, and determine a type of data to transfer the datato a remote cloud-based medical analytics network 204 based on inclusionor exclusion of data associated with a users, patient, or surgicalprocedure.

In another aspect, the memory 249 stores instructions executable by theprocessor 244 to receive new operational parameters for the surgical hub206 or the surgical instrument 235.

In various aspects, the present disclosure provides a control circuit todetermine, rate, frequency and type of data to transfer the data to theremote cloud-based medical analytics network as described above. Invarious aspects, the present disclosure provides a non-transitorycomputer-readable medium storing computer readable instructions which,when executed, causes a machine to determine, rate, frequency and typeof data to transfer to the remote cloud-based medical analytics network.

In one aspect, the surgical hub 206 is configured to determine what datato transmit to the cloud based analytics system 204. For example, asurgical hub 206 modular device 235 that includes local processingcapabilities may determine the rate, frequency, and type of data to betransmitted to the cloud based analytics system 204 for analysis andprocessing.

In one aspect, the surgical hub 206 comprises a modular communicationhub 203 and storage device 248 for storing parameters and status of adevice 235 that has the ability to determine when and how often data canbe shared with a cloud based analytics system 204, the transmission rateand the type of data that can be shared with the cloud based analyticssystem 204. In another aspect, the cloud analytics system 204communicates new operational parameters for the surgical hub 206 andsurgical devices 235 coupled to the surgical hub 206. A cloud basedanalytics system 204 is described in commonly owned U.S. ProvisionalPatent Application Ser. No. 62/611,340, filed Dec. 28, 2017, and titledCLOUD-BASED MEDICAL ANALYTICS, which is incorporated herein by referencein its entirety.

In one aspect, a device 235 coupled to a local surgical hub 206determines when and what data is transmitted to the cloud analyticssystem 204 for company analytic improvements. In one example, theavailable local data storage capacity remaining in the storage device248 controls the timing and rate at which the data is exported. Inanother example, user defined inclusion or exclusion of specific users,patients, or procedures allows data sets to be included for analysis orautomatically deleted. In yet another example, detected network downtime or available capacity determines the time of uploads orcommunications.

In another aspect, transmission of data for diagnosis of failure modesis keyed by specific incidents. For example, user defined failure of adevice, instrument, or tool within a procedure initiates archiving andtransmission of data recorded with respect to that instrument forfailure modes analysis. Further, when a failure event is identified, allthe data surrounding the event is archived and packaged for sending backfor predictive informatics (PI) analytics. Data that is part of a PIfailure is flagged for storage and maintenance until either the hospitalor the cloud based analytics system releases the hold on the data.

Catastrophic failures of instruments may initiate an automatic archiveand submission of data for implications analysis. Detection of acounterfeit component or adapter on an original equipment manufacturer(OEM) device initiates documentation of the component and recording ofthe results and outcome of its use.

FIG. 40 is a logic flow diagram 4320 of a process depicting a controlprogram or a logic configuration for determining rate, frequency, andtype of data to transfer to a remote cloud-based analytics network,according to one aspect of the present disclosure. With reference toFIGS. 1-40, in one aspect, the present disclosure provides a surgicalhub 206 comprising a storage device 248, a processor 244 coupled to thestorage device 248, and a memory 249 coupled to the processor 244. Thememory 249 stores instructions executable by the processor 244 toreceive 4322 data from a surgical instrument 235, determine 4324 a rateat which to transfer the data to a remote cloud-based medical analyticsnetwork 204 based on available storage capacity of the storage device248. Optionally, the memory 249 stores instructions executable by theprocessor 244 to determine 4326 a frequency at which to transfer thedata to the remote cloud-based medical analytics network 204 based onthe available storage capacity of the storage device 248. Optionally,the memory 249 stores instructions executable by the processor 244 todetect surgical hub network downtime and to determine 4326 a frequencyat which to transfer the data to the remote cloud-based medicalanalytics network 204 based on the detected surgical hub network 206down time. Optionally, the memory 249 stores instructions executable bythe processor 244 to determine 4328 a type of data to transfer the datato a remote cloud-based medical analytics network 204 based on inclusionor exclusion of data associated with a users, patient, or surgicalprocedure.

In another aspect, the memory 249 stores instructions executable by theprocessor 244 to receive new operational parameters for the surgical hub206 or the surgical instrument 235.

Situational awareness is the ability of some aspects of a surgicalsystem to determine or infer information related to a surgical procedurefrom data received from databases and/or instruments. The informationcan include the type of procedure being undertaken, the type of tissuebeing operated on, or the body cavity that is the subject of theprocedure. With the contextual information related to the surgicalprocedure, the surgical system can, for example, improve the manner inwhich it controls the modular devices (e.g., a robotic arm and/orrobotic surgical tool) that are connected to it and providecontextualized information or suggestions to the surgeon during thecourse of the surgical procedure.

Referring now to FIG. 41, a timeline 5200 depicting situationalawareness of a hub, such as the surgical hub 106 or 206, for example, isdepicted. The timeline 5200 is an illustrative surgical procedure andthe contextual information that the surgical hub 106, 206 can derivefrom the data received from the data sources at each step in thesurgical procedure. The timeline 5200 depicts the typical steps thatwould be taken by the nurses, surgeons, and other medical personnelduring the course of a lung segmentectomy procedure, beginning withsetting up the operating theater and ending with transferring thepatient to a post-operative recovery room.

The situationally aware surgical hub 106, 206 receives data from thedata sources throughout the course of the surgical procedure, includingdata generated each time medical personnel utilize a modular device thatis paired with the surgical hub 106, 206. The surgical hub 106, 206 canreceive this data from the paired modular devices and other data sourcesand continually derive inferences (i.e., contextual information) aboutthe ongoing procedure as new data is received, such as which step of theprocedure is being performed at any given time. The situationalawareness system of the surgical hub 106, 206 is able to, for example,record data pertaining to the procedure for generating reports, verifythe steps being taken by the medical personnel, provide data or prompts(e.g., via a display screen) that may be pertinent for the particularprocedural step, adjust modular devices based on the context (e.g.,activate monitors, adjust the field of view (FOV) of the medical imagingdevice, or change the energy level of an ultrasonic surgical instrumentor RF electrosurgical instrument), and take any other such actiondescribed above.

As the first step S202 in this illustrative procedure, the hospitalstaff members retrieve the patient's EMR from the hospital's EMRdatabase. Based on select patient data in the EMR, the surgical hub 106,206 determines that the procedure to be performed is a thoracicprocedure.

Second step S204, the staff members scan the incoming medical suppliesfor the procedure. The surgical hub 106, 206 cross-references thescanned supplies with a list of supplies that are utilized in varioustypes of procedures and confirms that the mix of supplies corresponds toa thoracic procedure. Further, the surgical hub 106, 206 is also able todetermine that the procedure is not a wedge procedure (because theincoming supplies either lack certain supplies that are necessary for athoracic wedge procedure or do not otherwise correspond to a thoracicwedge procedure).

Third step S206, the medical personnel scan the patient band via ascanner that is communicably connected to the surgical hub 106, 206. Thesurgical hub 106, 206 can then confirm the patient's identity based onthe scanned data.

Fourth step S208, the medical staff turns on the auxiliary equipment.The auxiliary equipment being utilized can vary according to the type ofsurgical procedure and the techniques to be used by the surgeon, but inthis illustrative case they include a smoke evacuator, insufflator, andmedical imaging device. When activated, the auxiliary equipment that aremodular devices can automatically pair with the surgical hub 106, 206that is located within a particular vicinity of the modular devices aspart of their initialization process. The surgical hub 106, 206 can thenderive contextual information about the surgical procedure by detectingthe types of modular devices that pair with it during this pre-operativeor initialization phase. In this particular example, the surgical hub106, 206 determines that the surgical procedure is a VATS procedurebased on this particular combination of paired modular devices. Based onthe combination of the data from the patient's EMR, the list of medicalsupplies to be used in the procedure, and the type of modular devicesthat connect to the hub, the surgical hub 106, 206 can generally inferthe specific procedure that the surgical team will be performing. Oncethe surgical hub 106, 206 knows what specific procedure is beingperformed, the surgical hub 106, 206 can then retrieve the steps of thatprocedure from a memory or from the cloud and then cross-reference thedata it subsequently receives from the connected data sources (e.g.,modular devices and patient monitoring devices) to infer what step ofthe surgical procedure the surgical team is performing.

Fifth step S210, the staff members attach the EKG electrodes and otherpatient monitoring devices to the patient. The EKG electrodes and otherpatient monitoring devices are able to pair with the surgical hub 106,206. As the surgical hub 106, 206 begins receiving data from the patientmonitoring devices, the surgical hub 106, 206 thus confirms that thepatient is in the operating theater.

Sixth step S212, the medical personnel induce anesthesia in the patient.The surgical hub 106, 206 can infer that the patient is under anesthesiabased on data from the modular devices and/or patient monitoringdevices, including EKG data, blood pressure data, ventilator data, orcombinations thereof, for example. Upon completion of the sixth stepS212, the pre-operative portion of the lung segmentectomy procedure iscompleted and the operative portion begins.

Seventh step S214, the patient's lung that is being operated on iscollapsed (while ventilation is switched to the contralateral lung). Thesurgical hub 106, 206 can infer from the ventilator data that thepatient's lung has been collapsed, for example. The surgical hub 106,206 can infer that the operative portion of the procedure has commencedas it can compare the detection of the patient's lung collapsing to theexpected steps of the procedure (which can be accessed or retrievedpreviously) and thereby determine that collapsing the lung is the firstoperative step in this particular procedure.

Eighth step S216, the medical imaging device (e.g., a scope) is insertedand video from the medical imaging device is initiated. The surgical hub106, 206 receives the medical imaging device data (i.e., video or imagedata) through its connection to the medical imaging device. Upon receiptof the medical imaging device data, the surgical hub 106, 206 candetermine that the laparoscopic portion of the surgical procedure hascommenced. Further, the surgical hub 106, 206 can determine that theparticular procedure being performed is a segmentectomy, as opposed to alobectomy (note that a wedge procedure has already been discounted bythe surgical hub 106, 206 based on data received at the second step S204of the procedure). The data from the medical imaging device 124 (FIG. 2)can be utilized to determine contextual information regarding the typeof procedure being performed in a number of different ways, including bydetermining the angle at which the medical imaging device is orientedwith respect to the visualization of the patient's anatomy, monitoringthe number or medical imaging devices being utilized (i.e., that areactivated and paired with the surgical hub 106, 206), and monitoring thetypes of visualization devices utilized. For example, one technique forperforming a VATS lobectomy places the camera in the lower anteriorcorner of the patient's chest cavity above the diaphragm, whereas onetechnique for performing a VATS segmentectomy places the camera in ananterior intercostal position relative to the segmental fissure. Usingpattern recognition or machine learning techniques, for example, thesituational awareness system can be trained to recognize the positioningof the medical imaging device according to the visualization of thepatient's anatomy. As another example, one technique for performing aVATS lobectomy utilizes a single medical imaging device, whereas anothertechnique for performing a VATS segmentectomy utilizes multiple cameras.As yet another example, one technique for performing a VATSsegmentectomy utilizes an infrared light source (which can becommunicably coupled to the surgical hub as part of the visualizationsystem) to visualize the segmental fissure, which is not utilized in aVATS lobectomy. By tracking any or all of this data from the medicalimaging device, the surgical hub 106, 206 can thereby determine thespecific type of surgical procedure being performed and/or the techniquebeing used for a particular type of surgical procedure.

Ninth step S218, the surgical team begins the dissection step of theprocedure. The surgical hub 106, 206 can infer that the surgeon is inthe process of dissecting to mobilize the patient's lung because itreceives data from the RF or ultrasonic generator indicating that anenergy instrument is being fired. The surgical hub 106, 206 cancross-reference the received data with the retrieved steps of thesurgical procedure to determine that an energy instrument being fired atthis point in the process (i.e., after the completion of the previouslydiscussed steps of the procedure) corresponds to the dissection step. Incertain instances, the energy instrument can be an energy tool mountedto a robotic arm of a robotic surgical system.

Tenth step S220, the surgical team proceeds to the ligation step of theprocedure. The surgical hub 106, 206 can infer that the surgeon isligating arteries and veins because it receives data from the surgicalstapling and cutting instrument indicating that the instrument is beingfired. Similarly to the prior step, the surgical hub 106, 206 can derivethis inference by cross-referencing the receipt of data from thesurgical stapling and cutting instrument with the retrieved steps in theprocess. In certain instances, the surgical instrument can be a surgicaltool mounted to a robotic arm of a robotic surgical system.

Eleventh step S222, the segmentectomy portion of the procedure isperformed. The surgical hub 106, 206 can infer that the surgeon istransecting the parenchyma based on data from the surgical stapling andcutting instrument, including data from its cartridge. The cartridgedata can correspond to the size or type of staple being fired by theinstrument, for example. As different types of staples are utilized fordifferent types of tissues, the cartridge data can thus indicate thetype of tissue being stapled and/or transected. In this case, the typeof staple being fired is utilized for parenchyma (or other similartissue types), which allows the surgical hub 106, 206 to infer that thesegmentectomy portion of the procedure is being performed.

Twelfth step S224, the node dissection step is then performed. Thesurgical hub 106, 206 can infer that the surgical team is dissecting thenode and performing a leak test based on data received from thegenerator indicating that an RF or ultrasonic instrument is being fired.For this particular procedure, an RF or ultrasonic instrument beingutilized after parenchyma was transected corresponds to the nodedissection step, which allows the surgical hub 106, 206 to make thisinference. It should be noted that surgeons regularly switch back andforth between surgical stapling/cutting instruments and surgical energy(i.e., RF or ultrasonic) instruments depending upon the particular stepin the procedure because different instruments are better adapted forparticular tasks. Therefore, the particular sequence in which thestapling/cutting instruments and surgical energy instruments are usedcan indicate what step of the procedure the surgeon is performing.Moreover, in certain instances, robotic tools can be utilized for one ormore steps in a surgical procedure and/or handheld surgical instrumentscan be utilized for one or more steps in the surgical procedure. Thesurgeon(s) can alternate between robotic tools and handheld surgicalinstruments and/or can use the devices concurrently, for example. Uponcompletion of the twelfth step S224, the incisions are closed up and thepost-operative portion of the procedure begins.

Thirteenth step S226, the patient's anesthesia is reversed. The surgicalhub 106, 206 can infer that the patient is emerging from the anesthesiabased on the ventilator data (i.e., the patient's breathing rate beginsincreasing), for example.

Lastly, the fourteenth step S228 is that the medical personnel removethe various patient monitoring devices from the patient. The surgicalhub 106, 206 can thus infer that the patient is being transferred to arecovery room when the hub loses EKG, BP, and other data from thepatient monitoring devices. As can be seen from the description of thisillustrative procedure, the surgical hub 106, 206 can determine or inferwhen each step of a given surgical procedure is taking place accordingto data received from the various data sources that are communicablycoupled to the surgical hub 106, 206.

Situational awareness is further described in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, which is incorporated by reference herein in itsentirety. In certain instances, operation of a robotic surgical system,including the various robotic surgical systems disclosed herein, forexample, can be controlled by the hub 106, 206 based on its situationalawareness and/or feedback from the components thereof and/or based oninformation from the cloud 102.

In one aspect, the present disclosure provides a surgical hub,comprising: a processor; and a memory coupled to the processor, thememory storing instructions executable by the processor to: interrogatea surgical instrument, wherein the surgical instrument is a first sourceof patient data; retrieve a first data set from the surgical instrument,wherein the first data set is associated with a patient and a surgicalprocedure; interrogate a medical imaging device, wherein the medicalimaging device is a second source of patient data; retrieve a seconddata set from the medical imaging device, wherein the second data set isassociated with the patient and an outcome of the surgical procedure;associate the first and second data sets by a key; and transmit theassociated first and second data sets to remote network outside of thesurgical hub. The present disclosure further provides, a surgical hubwherein the memory stores instructions executable by the processor to:retrieve the first data set using the key; anonymize the first data setby removing its association with the patient; retrieve the second dataset using the key; anonymize the second data set by removing itsassociation with the patient; pair the anonymized first and second datasets; and determine success rates of surgical procedures grouped by thesurgical procedure based on the anonymized paired first and second datasets. The present disclosure further provides a surgical hub, whereinthe memory stores instructions executable by the processor to: retrievethe anonymized first data set; retrieve the anonymized second data set;and reintegrate the anonymized first and second data sets using the key.The present disclosure further provides a surgical hub, wherein thefirst and second data sets define first and second data payloads inrespective first and second data packets. The present disclosure furtherprovides a control circuit to perform any one of the above recitedfunctions and/or a non-transitory computer readable medium storingcomputer readable instructions which, when executed, causes a machine toperform any one of the above recited functions.

In another aspect, the present disclosure provides a surgical hub,comprising: a processor; and a memory coupled to the processor, thememory storing instructions executable by the processor to: receive afirst data packet from a first source, the first data packet comprisinga first preamble, a first data payload, a source of the first datapayload, and a first encryption certificate, wherein the first preambledefines the first data payload and the first encryption certificateverifies the authenticity of the first data packet; receive a seconddata packet from a second source, the second data packet comprising asecond preamble, a second data payload, a source of the second datapayload, and a second encryption certificate, wherein the secondpreamble defines the second data payload and the second encryptioncertificate verifies the authenticity of the second data packet;associate the first and second data packets; and generate a third datapacket comprising the first and second data payloads. The presentdisclosure further provides a surgical hub, wherein the memory storesinstructions executable by the processor to: determine that a datapayload is from a new source; verify the new source of the data payload;and alter a data collection process at the surgical hub to receivesubsequent data packets from the new source. The present disclosurefurther provides a surgical, wherein the memory stores instructionsexecutable by the processor to associate the first and second datapackets based on a key. The present disclosure further provides asurgical hub, wherein the memory stores instructions executable by theprocessor to anonymize the data payload of the third data packet. Thepresent disclosure further provides a surgical hub, wherein the memorystores instructions executable by the processor to receive an anonymizedthird data packet and reintegrate the anonymized third data packet intothe first and second data packets using the key. The present disclosurefurther provides a control circuit to perform any one of the aboverecited functions and/or a non-transitory computer readable mediumstoring computer readable instructions which, when executed, causes amachine to perform any one of the above recited functions.

In another aspect, the present disclosure provides a surgical hubconfigured to communicate with a surgical instrument, the surgical hubcomprising: a processor; and a memory coupled to the processor, thememory storing instructions executable by the processor to: receive afirst data set associated with a surgical procedure, wherein the firstdata set is generated at a first time; receive a second data setassociated with the efficacy of the surgical procedure, wherein thesecond data set is generated at a second time, wherein the second timeis separate and distinct from the first time; anonymize the first andsecond data sets by removing information that identifies a patient, asurgery, or a scheduled time of the surgery; and store the first andsecond anonymized data sets to generate a data pair grouped by surgery.The present disclosure further provides a surgical hub, wherein thememory stores instructions executable by the processor to reconstruct aseries of chronological events based on the data pair. The presentdisclosure further provides a surgical hub, wherein the memory storesinstructions executable by the processor to reconstruct a series ofcoupled but unconstrained data sets based on the data pair. The presentdisclosure further provides a surgical hub, wherein the memory storesinstructions executable by the processor to: encrypt the data pair;define a backup format for the data pair; and mirror the data pair to acloud storage device. The present disclosure further provides a controlcircuit to perform any one of the above recited functions and/or anon-transitory computer readable medium storing computer readableinstructions which, when executed, causes a machine to perform any oneof the above recited functions.

In another aspect, the present disclosure provides a surgical hubcomprising: a storage device; a processor coupled to the storage device;and a memory coupled to the processor, the memory storing instructionsexecutable by the processor to: receive data from a surgical instrument;determine a rate at which to transfer the data to a remote cloud-basedmedical analytics network based on available storage capacity of thestorage device; determine a frequency at which to transfer the data tothe remote cloud-based medical analytics network based on the availablestorage capacity of the storage device or detected surgical hub networkdown time; and determine a type of data to transfer the data to a remotecloud-based medical analytics network based on inclusion or exclusion ofdata associated with a users, patient, or surgical procedure. Thepresent disclosure further provides a surgical hub, wherein the memorystores instructions executable by the processor to receive newoperational parameters for the surgical hub or the surgical instrument.The present disclosure further provides a control circuit to perform anyone of the above recited functions and/or a non-transitory computerreadable medium storing computer readable instructions which, whenexecuted, causes a machine to perform any one of the above recitedfunctions.

In another aspect, the present disclosure provides a surgical hubcomprising: a control configured to: receive data from a surgicalinstrument; determine a rate at which to transfer the data to a remotecloud-based medical analytics network based on available storagecapacity of the storage device; determine a frequency at which totransfer the data to the remote cloud-based medical analytics networkbased on the available storage capacity of the storage device ordetected surgical hub network down time; and determine a type of data totransfer the data to a remote cloud-based medical analytics networkbased on inclusion or exclusion of data associated with a users,patient, or surgical procedure.

Various aspects of the subject matter described herein are set out inthe following numbered examples.

Example 1. A surgical hub, comprising: a processor; a memory coupled tothe processor, the memory storing instructions executable by theprocessor to: interrogate a modular device coupled to the processor viaa modular communication hub, wherein the modular device is a source ofdata sets that include patient identity data and surgical proceduredata; receive a data set from the modular device; discard the patientidentity data and any portion of the surgical procedure data thatidentifies the patient from the data set; extract anonymous data fromthe data set and create an anonymized data set; and configure operationof the surgical hub or the modular device based on the anonymized dataset.

Example 2. The surgical hub of Example 1, wherein the anonymized dataset includes catastrophic failure of a modular device, and wherein thememory stores instructions executable by the processor to initiateautomatic archive and submission of data for implications analysis basedon the catastrophic failure of the modular device.

Example 3. The surgical hub of any one of Examples 1-2, wherein thememory stores instructions executable by the processor to detectcounterfeit component information from the anonymized data set.

Example 4. The surgical hub of any one of Examples 1-3, wherein thememory stores instructions executable by the processor to deriveimplications of the modular device from the anonymized data set.

Example 5. The surgical hub of any one of Examples 1-4, wherein thememory stores instructions executable by the processor to configure themodular device to operate based on the derived implications.

Example 6. The surgical hub of any one of Examples 1-5, wherein thememory stores instructions executable by the processor to configure thesurgical hub based on the derived implications.

Example 7. The surgical hub of any one of Examples 1-6, wherein thememory stores instructions executable by the processor to conglomeratethe anonymized data.

Example 8. The surgical hub of any one of Examples 1-7, wherein thememory stores instructions executable by the processor to extract theanonymized data prior to storing the received data in a storage devicecoupled to the surgical hub.

Example 9. The surgical hub of any one of Examples 1-8, wherein thememory stores instructions executable by the processor to: transmit theanonymized data to a remote network outside of the surgical hub; compilethe anonymized data at the remote network; and store a copy of the dataset from the modular device in a patient electronic medical recordsdatabase.

Example 10. The surgical hub of any one of Examples 1-9, comprising amodular communication hub coupled to the processor, the modularcommunication hub configured to connect modular devices located in oneor more operating theaters to the surgical hub.

Example 11. A method of stripping data originating from a modular devicecoupled to a surgical hub by a communication hub, the surgical hubcomprising a processor and a memory coupled to the processor, the memorystoring instructions executable by the processor, the method comprising:interrogating, by a processor, a modular device coupled to the processorvia a modular communication hub, wherein the modular communication hubis configured to connect modular devices located in one or moreoperating theaters to a surgical hub, wherein the modular device is asource of data sets that include patient identity data and surgicalprocedure data; receiving, by the processor, a data set from the modulardevice by the processor via the communication hub; discarding, by theprocessor, the patient identity data and any portion of the surgicalprocedure data that identifies the patient from the data set;extracting, by the processor, anonymous data from the data set andcreate an anonymized data set; and configuring, by the processor,operation of the surgical hub or the modular device based on theanonymized data set.

Example 12. The method of Example 11, comprising: initiating, by theprocessor, automatic archive and submission of data for implicationsanalysis based on the catastrophic failure of the modular device whereinthe anonymized data set includes catastrophic failure of a modulardevice.

Example 13. The method of any one of Examples 11-12, comprising by theprocessor, detecting counterfeit component information from theanonymized data set.

Example 14. The method of any one of Examples 11-13, comprising derivingimplications of the modular device from the anonymized data set.

Example 15. The method of Example 14, comprising configuring, by theprocessor, the modular device to operate based on the derivedimplications.

Example 16. The method of any one of Examples 14-15, comprisingconfiguring, by the processor, the surgical hub based on the derivedimplications.

Example 17. The method of any one of Examples 14-16, comprising,conglomerating by the processor, the anonymized data.

Example 18. The method of Example 11, extracting, by the processor, theanonymized data prior to storing the received data in a storage devicecoupled to the surgical hub.

Example 19. The method of Example 11, comprising: transmitting, by theprocessor, the anonymized data to a remote network outside of thesurgical hub; compiling, by a server at the remote network, theanonymized data at the remote network; and storing, by the processor, acopy of the data set from the modular device in a patient electronicmedical records database.

Example 20. A non-transitory computer readable medium storing computerreadable instructions which, when executed, causes a machine to:interrogate a modular device coupled to the processor via the modularcommunication hub, wherein the modular device is a source of data setsthat include patient identity data and surgical procedure data; receivea data set from the modular device; discard the patient identity dataand any portion of the surgical procedure data that identifies thepatient from the data set; extract anonymous data from the data set andcreate an anonymized data set; and configure operation of the surgicalhub or the modular device based on the anonymized data set.

Example 21. The non-transitory computer readable medium of Example 20,storing computer readable instructions which, when executed, causes amachine to derive implications of the modular device from the anonymizeddata set.

While several forms have been illustrated and described, it is not theintention of the applicant to restrict or limit the scope of theappended claims to such detail. Numerous modifications, variations,changes, substitutions, combinations, and equivalents to those forms maybe implemented and will occur to those skilled in the art withoutdeparting from the scope of the present disclosure. Moreover, thestructure of each element associated with the described forms can bealternatively described as a means for providing the function performedby the element. Also, where materials are disclosed for certaincomponents, other materials may be used. It is therefore to beunderstood that the foregoing description and the appended claims areintended to cover all such modifications, combinations, and variationsas falling within the scope of the disclosed forms. The appended claimsare intended to cover all such modifications, variations, changes,substitutions, modifications, and equivalents.

The foregoing detailed description has set forth various forms of thedevices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, and/or examples can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, or virtually any combination thereof.Those skilled in the art will recognize that some aspects of the formsdisclosed herein, in whole or in part, can be equivalently implementedin integrated circuits, as one or more computer programs running on oneor more computers (e.g., as one or more programs running on one or morecomputer systems), as one or more programs running on one or moreprocessors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one of skillin the art in light of this disclosure. In addition, those skilled inthe art will appreciate that the mechanisms of the subject matterdescribed herein are capable of being distributed as one or more programproducts in a variety of forms, and that an illustrative form of thesubject matter described herein applies regardless of the particulartype of signal bearing medium used to actually carry out thedistribution.

Instructions used to program logic to perform various disclosed aspectscan be stored within a memory in the system, such as dynamic randomaccess memory (DRAM), cache, flash memory, or other storage.Furthermore, the instructions can be distributed via a network or by wayof other computer readable media. Thus a machine-readable medium mayinclude any mechanism for storing or transmitting information in a formreadable by a machine (e.g., a computer), but is not limited to, floppydiskettes, optical disks, compact disc, read-only memory (CD-ROMs), andmagneto-optical disks, read-only memory (ROMs), random access memory(RAM), erasable programmable read-only memory (EPROM), electricallyerasable programmable read-only memory (EEPROM), magnetic or opticalcards, flash memory, or a tangible, machine-readable storage used in thetransmission of information over the Internet via electrical, optical,acoustical or other forms of propagated signals (e.g., carrier waves,infrared signals, digital signals, etc.). Accordingly, thenon-transitory computer-readable medium includes any type of tangiblemachine-readable medium suitable for storing or transmitting electronicinstructions or information in a form readable by a machine (e.g., acomputer).

As used in any aspect herein, the term “control circuit” may refer to,for example, hardwired circuitry, programmable circuitry (e.g., acomputer processor comprising one or more individual instructionprocessing cores, processing unit, processor, microcontroller,microcontroller unit, controller, digital signal processor (DSP),programmable logic device (PLD), programmable logic array (PLA), orfield programmable gate array (FPGA)), state machine circuitry, firmwarethat stores instructions executed by programmable circuitry, and anycombination thereof. The control circuit may, collectively orindividually, be embodied as circuitry that forms part of a largersystem, for example, an integrated circuit (IC), an application-specificintegrated circuit (ASIC), a system on-chip (SoC), desktop computers,laptop computers, tablet computers, servers, smart phones, etc.Accordingly, as used herein “control circuit” includes, but is notlimited to, electrical circuitry having at least one discrete electricalcircuit, electrical circuitry having at least one integrated circuit,electrical circuitry having at least one application specific integratedcircuit, electrical circuitry forming a general purpose computing deviceconfigured by a computer program (e.g., a general purpose computerconfigured by a computer program which at least partially carries outprocesses and/or devices described herein, or a microprocessorconfigured by a computer program which at least partially carries outprocesses and/or devices described herein), electrical circuitry forminga memory device (e.g., forms of random access memory), and/or electricalcircuitry forming a communications device (e.g., a modem, communicationsswitch, or optical-electrical equipment). Those having skill in the artwill recognize that the subject matter described herein may beimplemented in an analog or digital fashion or some combination thereof.

As used in any aspect herein, the term “logic” may refer to an app,software, firmware and/or circuitry configured to perform any of theaforementioned operations. Software may be embodied as a softwarepackage, code, instructions, instruction sets and/or data recorded onnon-transitory computer readable storage medium. Firmware may beembodied as code, instructions or instruction sets and/or data that arehard-coded (e.g., nonvolatile) in memory devices.

As used in any aspect herein, the terms “component,” “system,” “module”and the like can refer to a computer-related entity, either hardware, acombination of hardware and software, software, or software inexecution.

As used in any aspect herein, an “algorithm” refers to a self-consistentsequence of steps leading to a desired result, where a “step” refers toa manipulation of physical quantities and/or logic states which may,though need not necessarily, take the form of electrical or magneticsignals capable of being stored, transferred, combined, compared, andotherwise manipulated. It is common usage to refer to these signals asbits, values, elements, symbols, characters, terms, numbers, or thelike. These and similar terms may be associated with the appropriatephysical quantities and are merely convenient labels applied to thesequantities and/or states.

A network may include a packet switched network. The communicationdevices may be capable of communicating with each other using a selectedpacket switched network communications protocol. One examplecommunications protocol may include an Ethernet communications protocolwhich may be capable permitting communication using a TransmissionControl Protocol/Internet Protocol (TCP/IP). The Ethernet protocol maycomply or be compatible with the Ethernet standard published by theInstitute of Electrical and Electronics Engineers (IEEE) titled “IEEE802.3 Standard”, published in December, 2008 and/or later versions ofthis standard. Alternatively or additionally, the communication devicesmay be capable of communicating with each other using an X.25communications protocol. The X.25 communications protocol may comply orbe compatible with a standard promulgated by the InternationalTelecommunication Union-Telecommunication Standardization Sector(ITU-T). Alternatively or additionally, the communication devices may becapable of communicating with each other using a frame relaycommunications protocol. The frame relay communications protocol maycomply or be compatible with a standard promulgated by ConsultativeCommittee for International Telegraph and Telephone (CCITT) and/or theAmerican National Standards Institute (ANSI). Alternatively oradditionally, the transceivers may be capable of communicating with eachother using an Asynchronous Transfer Mode (ATM) communications protocol.The ATM communications protocol may comply or be compatible with an ATMstandard published by the ATM Forum titled “ATM-MPLS NetworkInterworking 2.0” published August 2001, and/or later versions of thisstandard. Of course, different and/or after-developedconnection-oriented network communication protocols are equallycontemplated herein.

Unless specifically stated otherwise as apparent from the foregoingdisclosure, it is appreciated that, throughout the foregoing disclosure,discussions using terms such as “processing,” “computing,”“calculating,” “determining,” “displaying,” or the like, refer to theaction and processes of a computer system, or similar electroniccomputing device, that manipulates and transforms data represented asphysical (electronic) quantities within the computer system's registersand memories into other data similarly represented as physicalquantities within the computer system memories or registers or othersuch information storage, transmission or display devices.

One or more components may be referred to herein as “configured to,”“configurable to,” “operable/operative to,” “adapted/adaptable,” “ableto,” “conformable/conformed to,” etc. Those skilled in the art willrecognize that “configured to” can generally encompass active-statecomponents and/or inactive-state components and/or standby-statecomponents, unless context requires otherwise.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” refers to the portion closest to the clinician andthe term “distal” refers to the portion located away from the clinician.It will be further appreciated that, for convenience and clarity,spatial terms such as “vertical”, “horizontal”, “up”, and “down” may beused herein with respect to the drawings. However, surgical instrumentsare used in many orientations and positions, and these terms are notintended to be limiting and/or absolute.

Those skilled in the art will recognize that, in general, terms usedherein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitationis explicitly recited, those skilled in the art will recognize that suchrecitation should typically be interpreted to mean at least the recitednumber (e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flow diagrams arepresented in a sequence(s), it should be understood that the variousoperations may be performed in other orders than those which areillustrated, or may be performed concurrently. Examples of suchalternate orderings may include overlapping, interleaved, interrupted,reordered, incremental, preparatory, supplemental, simultaneous,reverse, or other variant orderings, unless context dictates otherwise.Furthermore, terms like “responsive to,” “related to,” or otherpast-tense adjectives are generally not intended to exclude suchvariants, unless context dictates otherwise.

It is worthy to note that any reference to “one aspect,” “an aspect,”“an exemplification,” “one exemplification,” and the like means that aparticular feature, structure, or characteristic described in connectionwith the aspect is included in at least one aspect. Thus, appearances ofthe phrases “in one aspect,” “in an aspect,” “in an exemplification,”and “in one exemplification” in various places throughout thespecification are not necessarily all referring to the same aspect.Furthermore, the particular features, structures or characteristics maybe combined in any suitable manner in one or more aspects.

Any patent application, patent, non-patent publication, or otherdisclosure material referred to in this specification and/or listed inany Application Data Sheet is incorporated by reference herein, to theextent that the incorporated materials is not inconsistent herewith. Assuch, and to the extent necessary, the disclosure as explicitly setforth herein supersedes any conflicting material incorporated herein byreference. Any material, or portion thereof, that is said to beincorporated by reference herein, but which conflicts with existingdefinitions, statements, or other disclosure material set forth hereinwill only be incorporated to the extent that no conflict arises betweenthat incorporated material and the existing disclosure material.

In summary, numerous benefits have been described which result fromemploying the concepts described herein. The foregoing description ofthe one or more forms has been presented for purposes of illustrationand description. It is not intended to be exhaustive or limiting to theprecise form disclosed. Modifications or variations are possible inlight of the above teachings. The one or more forms were chosen anddescribed in order to illustrate principles and practical application tothereby enable one of ordinary skill in the art to utilize the variousforms and with various modifications as are suited to the particular usecontemplated. It is intended that the claims submitted herewith definethe overall scope.

1. A surgical system configured to enhance a patient's privacy during asurgical procedure, the surgical system comprising: a surgicalinstrument configured for use during the surgical procedure; a databaseconfigured to store a medical record associated with the patient; and asurgical hub configured to be communicably coupled to the surgicalinstrument and the database, wherein the surgical hub comprises a memoryand a control circuit configured to: receive the medical record from thedatabase; determine that the medical record comprises medicalinformation and personal information associated with the patient; removethe medical information from the personal information; generate ananonymous data file that exclusively comprises the medical information;and generate a recommended action for the surgical instrument based, atleast in part, on the anonymous data file.
 2. The surgical system ofclaim 1, wherein the control circuit is further configured to:temporarily store the personal information in the memory; generate areassembled data file comprising the personal information temporarilystored in the memory and the medical information; and delete thepersonal information temporarily stored in the memory of the surgicalhub.
 3. The surgical system of claim 2, wherein the database is furtherconfigured to store a key that uniquely identifies the medical record,wherein the control circuit is further configured to receive the keyfrom the database, and wherein the generation of the reassembled datafile is based, at least in part, on the key.
 4. The surgical system ofclaim 2, wherein the control circuit is further configured to: receive asignal from the surgical instrument, wherein the signal is associatedwith information generated during the surgical procedure; determine thatthe information generated by the surgical instrument during the surgicalprocedure comprises personal information associated with the patientbased, at least in part, on the received signal; remove the medicalinformation generated by the surgical instrument during the surgicalprocedure from the personal information generated during the surgicalprocedure; and modify the anonymous data file to further comprise themedical information generated by the surgical instrument during thesurgical procedure.
 5. The surgical system of claim 4, wherein themedical information generated by the surgical instrument comprises asurgical outcome.
 6. The surgical system of claim 5, further comprisinga cloud-based analytics subsystem configured to analyze surgical outcomedata, wherein the control circuit is further configured to transmit theanonymous data file to the cloud-based analytics subsystem.
 7. Thesurgical system of claim 6, wherein the cloud-based analytics subsystemis separated from the surgical hub and the database by a hospital databarrier, and wherein data located outside the hospital data barrierexclusively comprises medical information associated with the patient tomaintain anonymity.
 8. The surgical system of claim 7, wherein thedatabase is further configured to store a key that uniquely identifiesthe medical record, and wherein accessing the medical record is based,at least in part, on the key.
 9. The surgical system of claim 8, whereinthe memory is configured to locally store the key in an encryptedformat.
 10. The surgical system of claim 1, wherein the recommendedaction comprises a suggested configuration for the surgical instrument.11. The surgical system of claim 1, wherein the recommended actioncomprises a suggested operation for the surgical instrument.
 12. Thesurgical system of claim 1, wherein the medical information comprises atleast one of: a diagnosis associated with the patient, a pre-operativetreatment associated with the patient, and a patient parameter thatalone cannot be used to ascertain the identity of the patient, orcombinations thereof.
 13. The surgical system of claim 1, wherein thepersonal information comprises at least one of: an age of the patient,an employer of the patient, a body mass index of the patient, and apatient parameter that alone can be used to ascertain the identity ofthe patient, or combinations thereof.
 14. A surgical hub configured toenhance a patient's privacy during a surgical procedure, wherein thesurgical hub is configured to be communicably coupled to a surgicalinstrument and a database configured to store a medical recordassociated with the patient, the surgical hub comprising: a memory; anda control circuit configured to: receive the medical record from thedatabase; determine that the medical record comprises medicalinformation and personal information associated with the patient; removethe medical information from the personal information; generate ananonymous data file that exclusively comprises the medical information;and generate a recommended action for the surgical instrument based, atleast in part, on the anonymous data file.
 15. The surgical hub of claim14, wherein the control circuit is further configured to: temporarilystore the personal information in the memory; generate a reassembleddata file comprising the personal information temporarily stored in thememory and the medical information; and delete the personal informationtemporarily stored in the memory of the surgical hub.
 16. The surgicalhub of claim 14, wherein the control circuit is further configured to:receive a signal from the surgical instrument, wherein the signal isassociated with information generated during the surgical procedure;determine that the information generated by the surgical instrumentduring the surgical procedure comprises personal information associatedwith the patient based, at least in part, on the received signal; removethe medical information generated by the surgical instrument during thesurgical procedure from the personal information generated during thesurgical procedure; and modify the anonymous data file to furthercomprise the medical information generated by the surgical instrumentduring the surgical procedure.
 17. The surgical hub of claim 14, furthercomprising a cloud-based analytics subsystem configured to analyzesurgical outcome data, wherein the control circuit is further configuredto transmit the anonymous data file to the cloud-based analyticssubsystem.
 18. The surgical hub of claim 17, wherein the cloud-basedanalytics subsystem is separated from the surgical hub by a hospitaldata barrier, and wherein data located outside the hospital data barrierexclusively comprises medical information associated with the patient tomaintain anonymity.
 19. A method of enhancing a patient's privacy duringa surgical procedure, wherein data external to the data barrier isanonymous, and wherein the surgical procedure comprises a surgical hubconfigured to be communicably coupled to a database configured to storea medical record and a surgical instrument, the method comprising:retrieving a medical record from the database; determining that themedical record comprises medical information and personal informationassociated with the patient; removing the medical information from thepersonal information; generate an anonymous data file that exclusivelycomprises the medical information; and generating a recommended actionfor the surgical instrument based, at least in part, on the anonymousdata file.
 20. The method of claim 19, further comprising: receiving asignal from the surgical instrument, wherein the signal is associatedwith information generated during the surgical procedure; determiningthat the information generated by the surgical instrument during thesurgical procedure comprises personal information associated with thepatient based, at least in part, on the received signal; removing themedical information generated by the surgical instrument during thesurgical procedure from the personal information generated during thesurgical procedure; and modifying the anonymous data file to furthercomprise the medical information generated by the surgical instrumentduring the surgical procedure.